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<h3>Job Description</h3>
Job Description
ABOUT INSPIRE MEDICAL SYSTEMS
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients' lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.
WHY JOIN OUR FAST-GROWING TEAM
At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement. 
If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team! 
ESSENTIAL JOB FUNCTIONS 
The Manufacturing Test Engineer is responsible for supporting the development of cost-effective methods for testing Inspire products including implantable devices, external devices, and cloud systems.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE 
<ul>
<li>Supports the development of device and software test systems for all Inspire products and ensures high-capacity testing in production.</li>
<li>Collaborates closely with product team members. Supports the development of test equipment and methods and expedites the delivery of new products.</li>
<li>Develops product test specifications and procedures.</li>
<li>Manages vendors and other manufacturing partners by supporting and (as applicable) troubleshooting tests and test equipment released to production.</li>
<li>Supports the design and build of cloud-based production test control systems to ensure expandability after commercial release.</li>
<li>Defines, updates and implements test protocols by utilizing current engineering test methods and technologies.</li>
<li>Generates verification and validation documentation (ex: Test methods, test reports) in support of production activities.</li>
<li>Continuously evaluates and improves processes by collaborating with cross-functional groups.</li>
<li>Collaborates with manufacturing and operations to support all qualifications and validations of new test systems.</li>
</ul>
QUALITY SYSTEM RESPONSIBILITIES 
<ul>
<li>Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.</li>
<li>Complete training requirements and competency confirmations as required for this position within the required timeline.</li>
<li>Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.</li>
</ul>
WHAT YOU CAN BRING TO OUR GREAT TEAM
Required:
<ul>
<li>Bachelor's degree in Electrical Engineering, Software Engineering, or Biomedical Engineering</li>
<li>3+ years of relevant experience required</li>
<li>Strong automation/manual testing experience</li>
<li>Experience utilizing cloud computing and web technologies in support of medical products</li>
<li>Experience in managing and leading programs that are compliant with standards for good laboratory practices (GLP), good manufacturing practices (GMP) and good clinical practices (GCP).</li>
<li>Experience establishing and building relationships with internal resources, contract resources, and large vendors.</li>
<li>Excellent analytical skills</li>
</ul>
Preferred:
<ul>
<li>Master's degree in Electrical Engineering, Software Engineering, or Biomedical Engineering</li>
</ul>
#LI-Onsite
The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.
Salary$85,000—$135,000 USD
BENEFITS AND OTHER COMPENSATION
Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):
<ul>
<li>Multiple health insurance plan options.</li>
<li>Employer contributions to Health Savings Account.</li>
<li>Dental, Vision, Life and Disability benefits.</li>
<li>401k plan + employer match.</li>
<li>Identity Protection.</li>
<li>Flexible time off.</li>
<li>Tuition Reimbursement.</li>
<li>Employee Assistance program.</li>
<li>All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.</li>
</ul>
Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis. Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com Inspire Medical Systems participates in E-Verify.

Manufacturing Test Engineer

<h3>Job Description</h3>
Job Description
Writing
 
Job Title: Validation Engineer (Medical Device)
Location: Marietta, GA (Open to Local Candidates within Georgia)
Positions Available: 3
Employment Type: Contract through ProQuality Network
 
Summary
ProQuality Network is seeking highly skilled Validation Engineers to support our Medical Device client in Marietta, Georgia. This opportunity is open exclusively to local candidates within the state of Georgia and is offered on a contract basis. Selected professionals will play a key role in ensuring compliance with FDA, ISO, and international medical device regulations by executing robust validation protocols, qualifying equipment and systems, and collaborating cross-functionally to drive quality and operational excellence.
 
Key Responsibilities
<ul>
<li>Develop, execute, and maintain validation deliverables including Validation Master Plans (VMP), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).</li>
<li>Support validation of molding equipment, automated/manual assembly processes, robotics, conveyors, bowl feed systems, and servo/PLC-controlled systems.</li>
<li>Assess fixture/tooling qualifications, ergonomic considerations, and environmental controls.</li>
<li>Conduct validation and qualification activities for MES/SCADA systems in FDA-regulated environments.</li>
<li>Perform testing such as torque, vision system evaluation, and functional performance validation.</li>
<li>Interpret and apply applicable regulations and standards, including 21 CFR Part 820 (FDA QSR), EU MDR 2017/745, ISO 9001, and ISO 13485.</li>
<li>Document all validation activities with strong technical writing and reporting standards.</li>
<li>Provide training to personnel on validation protocols, equipment usage, and compliance practices.</li>
<li>Collaborate with design, manufacturing, and quality teams to ensure alignment across functions.</li>
<li>Apply root cause analysis and problem-solving methodologies to address deviations and process gaps.</li>
</ul>
 
Required Qualifications
<ul>
<li>Bachelor’s degree (or higher) in Engineering (Mechanical, Biomedical, Chemical, Industrial, or related).</li>
<li>Strong experience with IQ/OQ/PQ protocols and equipment calibration procedures.</li>
<li>Knowledge of automated and manual assembly techniques, including robotics and process control systems.</li>
<li>Hands-on experience in medical device validation within a GMP/FDA-regulated environment.</li>
<li>Proficiency in technical documentation, reporting, and regulatory compliance.</li>
<li>Strong analytical mindset with proven problem-solving skills.</li>
</ul>
 
Preferred Qualifications
<ul>
<li>Certifications in ISO 14971 Risk Management and ISO 13485 Quality Management Systems.</li>
<li>Six Sigma/Lean Manufacturing credentials (Green Belt or Black Belt).</li>
<li>GMP training and proven understanding of international quality standards.</li>
<li>Experience with KNEAT software (highly desirable).</li>
</ul>
 
Application Note: This opportunity is exclusively open to local candidates in Georgia. Interested candidates are invited to apply through the job description link with an updated resume.

Validation Engineer (Medical Device Industry)

<h3>Job Description</h3>
Job Description
Staff Software Engineer, GPU Algorithms
We are looking for a full-time Staff Software Engineer, GPU Algorithms with a strong background in ultrasound, medical image reconstruction, and programming languages such as C++ and CUDA to shape our new ultrasound imaging platform.
As a Staff Software Engineer, you will work on developing and optimizing GPU algorithms and techniques related to ultrasound signal processing, image formation, and analysis. The primary focus of this software engineering role is to improve the quality, accuracy, and interpretation of ultrasound images for DeepSight's revolutionary Ultrasound system.
 
WE OFFER GREAT BENEFITS AND PERKS TO OUR SOFTWARE ENGINEERING TEAM:
<ul>
<li>Competitive salary of $170,000-$220,000</li>
<li>Stock options</li>
<li>Medical, dental, and vision insurance</li>
<li>401(k) retirement plan</li>
</ul>
 
AS A STAFF SOFTWARE ENGINEER SPECIALIZING IN GPU ALGORITHMS, YOUR RESPONSIBILITIES ARE:
<ul>
<li>Developing advanced beamforming techniques to enhance the spatial resolution and image quality of ultrasound scans.</li>
<li>Designing algorithms for image enhancement, noise reduction, edge detection, and speckle reduction in ultrasound images.</li>
<li>Developing algorithms for reconstructing 2D or 3D images from acquired ultrasound data. This involves handling data interpolation, scan conversion, and geometric transformations.</li>
<li>Designing algorithms to extract relevant features and perform segmentation of structures or regions of interest in ultrasound images.</li>
<li>Developing techniques to compensate for motion artifacts caused by patient movement or tissue motion during ultrasound scanning. This can involve image registration, motion estimation, and correction algorithms.</li>
<li>Exploring the application of machine learning and artificial intelligence (AI) techniques to improve ultrasound image analysis, automate diagnosis, or assist in image interpretation tasks.</li>
<li>Collaborating with systems and hardware engineers to optimize the integration of ultrasound imaging systems, ensuring efficient data acquisition, processing, and display.</li>
<li>Implement proposed solutions using C++ and CUDA programming languages.</li>
</ul>
 
REQUIRED QUALIFICATIONS:
<ul>
<li>BS in an engineering or computer science field</li>
<li>Familiarity in ultrasound physics, signal and image processing, beamforming, simulation, algorithm development, or tool development</li>
<li>Strong background in object-oriented programming, software architecture, and design patterns</li>
<li>Proficiency with C++ programming</li>
<li>Experience in concurrent/parallel programming-multithreading, multiprocessing, GPU acceleration (CUDA, CuPy, Numba, OpenCL, Halide)</li>
<li>Deep familiarity with common developer tool sets, including source control, continuous integration, and automated unit testing</li>
<li>Passionate about medical devices, with excellent communication and teamwork skills</li>
</ul>
 
PREFERRED QUALIFICATIONS FOR THIS SOFTWARE ENGINEERING ROLE:
<ul>
<li>PhD in Electrical/Biomedical engineering with a dissertation topic related to ultrasound imaging or therapy</li>
<li>5+ years of experience in commercial software development</li>
<li>Experience in medical imaging product development (FDA regulated)</li>
<li>Experience with real-time software applications</li>
<li>Experience interfacing with hardware components and systems</li>
<li>Knowledge of DICOM and HL7</li>
</ul>
 
QUALITIES WE ARE LOOKING FOR IN THIS STAFF SOFTWARE ENGINEER, GPU ALGORITHMS POSITION:
<ul>
<li>Positive - a can-do attitude that helps you rise to challenges</li>
<li>Collaborative - a team player who can effectively communicate with others</li>
<li>Attentive to detail - nothing gets by you</li>
<li>Efficient with a knack for effectively prioritizing tasks and managing your time</li>
<li>Proud of your work and real desire to do quality work</li>
<li>Career-minded - looking for more than a job</li>
<li>Empathetic - a mindset of producing quality products that help people</li>
</ul>
 
JOIN OUR SOFTWARE ENGINEERING TEAM!
Ready to take on the challenge? If you've got the drive to succeed and the hustle to make things happen, we're excited to have you join our team! Use our 3-minute initial application to apply now!
 Job Posted by ApplicantPro

Staff Software Engineer, GPU Algorithms

<h3>Job Description</h3>
About Us:
Precision Tube &amp; Catheter, Inc. (PT&amp;C) is a high-tech enterprise dedicated to the manufacturing of advanced materials and components，specializing in precision tubes and catheters for interventional and implantable medical devices. We produce high-quality medical tubes that meet stringent industry requirements for a diverse range of medical and pharmaceutical applications. Our commitment to innovation ensures that we exceed industry standards and support healthcare professionals in delivering effective patient care.
 
Position Summary:
We are seeking an experienced Manufacturing Process and Production Management professional. You will be a critical link between engineering, production operations, and quality assurance. You will not only understand the intricacies of precision tube and catheter manufacturing processes but also optimize them and lead teams to achieve key goals in safety, quality, delivery, and cost (SQDC). This role is vital to enhancing our competitiveness as a top-tier supplier in the medical device industry.
 
Key Responsibilities:
Process Management &amp; Optimization:
<ul>
<li>Own process development, validation, and qualification (including Operational Qualification/Performance Qualification) for new catheter products and precision tube components from NPI through to full-scale production.</li>
<li>Analyze, optimize, and standardize existing manufacturing processes to solve technical issues, continuously improving efficiency, yield, and capacity.</li>
<li>Lead Process Failure Mode and Effects Analysis (PFMEA) and the implementation of Control Plans.</li>
<li>Drive continuous improvement (Kaizen) and Lean Manufacturing initiatives, introducing automation and process enhancements.</li>
</ul>
Production Operations Management:
<ul>
<li>Manage and supervise the daily activities of production teams to ensure the production schedule is met on-time, in-full, and to specification.</li>
<li>Be accountable for production line performance metrics (KPIs) such as OEE, Output, and Scrap Rate through effective resource allocation and personnel scheduling.</li>
<li>Ensure the production floor strictly adheres to cGMP, ISO 13485, and relevant medical device regulations (e.g., 21 CFR Part 820) quality system requirements, maintaining an audit-ready state at all times.</li>
<li>Manage production-related Non-Conformance Reports (NCRs), deviation investigations, and Corrective and Preventive Actions (CAPA).</li>
</ul>
Cross-Functional Leadership &amp; Collaboration:
<ul>
<li>Work closely with R&amp;D to ensure the Design for Manufacturability (DFM) of new products6.</li>
<li>Collaborate with Quality Assurance (QA) and Quality Control (QC) departments to ensure products meet all specifications and standards.</li>
<li>Partner with Supply Chain and Procurement to optimize the use of raw materials and consumables.</li>
<li>Demonstrate excellent vertical management and horizontal collaboration skills9, enabling effective communication and collaboration with Chinese R&amp;D, production teams, and the local US team.</li>
</ul>
Qualifications &amp; Requirements:
Essential:
<ul>
<li>Bachelor's degree or higher in an Engineering discipline (Mechanical, Polymer Science, Biomedical, Industrial Engineering, etc.).</li>
<li>5+ years of hands-on experience in the medical device industry, specifically in catheters or similar interventional disposables in a process, manufacturing engineering, or production management role.</li>
<li>Strong technical foundation in catheter manufacturing processes; expertise in extrusion, braiding, tubing processing, assembly, and packaging is required. </li>
<li>Demonstrated practical experience with Lean Manufacturing and Continuous Improvement principles (e.g., 5S, VSM, TPM; Six Sigma Green/Black Belt is a plus).</li>
<li>In-depth knowledge of medical device quality management systems (ISO 13485, 21 CFR Part 820) and their application in production.</li>
<li>Excellent problem-solving, analytical, and project management skills.</li>
<li>Strong leadership, communication, and team management abilities.</li>
<li>Fluency in English (written and spoken). Proficiency in Mandarin Chinese is required to ensure smooth collaboration with China-based teams.</li>
</ul>
Preferred:
<ul>
<li>Experience with technology transfer or New Product Introduction (NPI) is a plus1.</li>
<li>Strong background in catheter manufacturing process technology is a plus2.</li>
<li>Experience working in cross-regional and cross-cultural teams is advantageous.</li>
<li>Familiarity with design software such as SolidWorks or AutoCAD is a plus3.</li>
</ul>
 
Benefits / Other:
We believe our employees are our greatest resource. We offer a competitive salary and benefits package including 401(k) with employer contribution, paid holidays, and vacation. Insurance coverage includes medical, dental, vision, and prescription drugs.We are proud to be an equal-opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status. If you have a disability or special need that requires accommodation, please let us know. If applying for positions in the U.S., you must be eligible to work in the U.S. without needing an employer-sponsored visa (work permit).
 
Why Join PT&amp;C?
<ul>
<li>Be part of a high-impact startup developing critical medical components.</li>
<li>Work closely with founders and engineers to shape company processes and culture.</li>
<li>Opportunity for rapid professional growth and ownership in building quality systems from the ground up.</li>
</ul>
 
To Apply: 
Please submit your resume and cover letter to <a href="mailto:Binbin.Su@ptncmed.com" target="_blank">Binbin.Su@ptncmed.com</a>. We look forward to reviewing your application!
 
Precision Tube &amp; Catheter, Inc. (<a href="https://www.ptncmed.com/" target="_blank">https://www.ptncmed.com/</a>) is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Process Engineer

<h3>Job Description</h3>
Job DescriptionDescription:
 
ProSource360 is seeking a full time BMET II to provide professional services and any work related to supporting medical equipment or HTM department operations for the Phoenix VA Health Care System (PVAHCS) for a one-year contract. PVAHCS provides healthcare to central Arizona at the main hospital in central Phoenix and 12 outlying clinics. The Biomedical Engineer will focus primarily on technology assessment, implementation, configuration management and healthcare consulting services. Professional services shall include, but are not limited to the following:
 
Technology Assessment:
<ul>
<li>Information Gathering – collect requested technical and clinical details related to local interface/device integrated systems to include providing system inventories, confirming, and working with local POCs for each system (Informatics, Biomed, etc.), and participating in gap analyses for the systems.</li>
<li>Specification Development – Support defining and validating the requirements, compliance, features, and functions for medical equipment and clinical systems through extensive stakeholder interaction, technical subject matter expertise, and market research.</li>
<li>Technical Analysis - Perform technical market analysis of medical equipment and clinical systems, considering clinical capabilities, technical performance, supportability, device integration, design and architecture, desired features, human factors design, ease of use, cost, and other factors.</li>
<li>Risk Assessment - Perform risk assessments of medical equipment and clinical systems in collaboration with clinical stakeholders, patient safety personnel, and with IT for human factors design, reliability, information security, data protection, and connectivity requirements. Submit information required for Enterprise Risk Assessments (ERAs).</li>
</ul>
Technology Implementation:
<ul>
<li>Project Management - Overall project management. Project management, coordination, and system configuration design with clinicians and vendors to implement new equipment/clinical systems. Includes preparation, participation, and leadership of meetings, conference calls, and communications. Includes creation, development, and upkeep of project documentation. This work is generally performed following issuance of purchase order or TO award for new equipment/systems and extends through first clinical use and transitions to operational sustainment.</li>
<li>Site Readiness - Collaborate with architects, engineers, equipment vendors, construction contractors, clinical services, IT, and others to ensure proper medical equipment and clinical systems siting, safety compliance, physical and remote connectivity, security documentation, and code compliance in preparation for major medical equipment and clinical system installations.</li>
<li>Preparation and Coordination – Coordinate with the Network POC for connectivity and testing; coordinate devices, hubs, cabinets or desktop installation needs to ensure availability/readiness; and coordinate with vendors to ensure connectivity requirements for interfaces and device integrated systems are met. Work with vendors and local SMEs to prepare local systems for testing, integration, and cut-over events. Work with vendors in coordinating local interface/device integrated systems resources for both cutover planning and go live support, including preparing events such as cutover planning events and production validation, as well as during cutover to production.</li>
<li>Installation and Inspection - Ensure equipment and systems are inspected and approved for implementation by validating specifications, performance levels, and electrical code compliance; performing functional testing, user acceptance testing, formal acceptance actions (per contract), and work associated with documentation; designing the equipment lifecycle strategies; developing preventative and corrective maintenance plan and standard operating procedures; facilitating proper user training; evaluating needs for system access and ensuring that the need to perform a task, permission levels, and competency requirements are met; ensuring proper nomenclature categorization; and assigning maintenance schedule(s) for new equipment and systems.</li>
<li>Systems Design and Integration - Address and evaluate multiple parameters to ensure that separate medical equipment and clinical systems work as complete, integrated systems (when necessary). </li>
<li>System Testing – Work with local resources to install applications or devices to testing devices when needed and participate in testing interfaces/device integrated system, both scheduled and ad hoc. Work with local and national teams for test scenario review and provide feedback when requested, troubleshoot issues and log service records if needed, and coordinate testing resources when troubleshooting issues.</li>
<li>Technical Training and Support - Provide or facilitate education and applications training for HTM staff and facilitate operator training around operating and maintaining medical equipment and clinical systems. Provide helpdesk and troubleshooting support for medical equipment and/or clinical systems.</li>
</ul>
Configuration Management:
<ul>
<li>Configuration - Arrange and document clinical system specifications, components, connectivity, and operating system and software versions; track and control changes; and validate and maintain consistency and completeness of the clinical system.</li>
</ul>
Technology Sustainment:
<ul>
<li>Safety Alerts, Recalls, and Incident Management - Manage, lead, and document activities associated with medical equipment and clinical systems safety, recalls, and incident investigations to prevent harm to patients, including proactive risk assessments, evidence preservation, data capture and analyses, root cause identification, corrective action development, solutions implementation, and disaster recovery. Set, monitor, and/or remediate clinical system alerts and failures, including performing remote monitoring and recovery.</li>
<li>Cybersecurity Risk Management - Directly support and monitor medical equipment and clinical system cybersecurity compliance, including: ensuring proper medical network security operations, conducting planned and proactive updates of devices and systems, providing quality assurance on medical system compatibility, ensuring equipment inspections and calibrations do not degrade medical equipment performance, performing security incident investigation and corrective action, and testing device communication and system reporting to validate the expected level of integration and interoperability exists.</li>
<li>Hardware and Software Upgrades - Proactively upgrade hardware and software to optimize patient safety and clinical efficacy through technology refresh cycles.</li>
</ul>
Healthcare Consulting:
<ul>
<li>Equipment and Systems Planning – Support assessing medical equipment and clinical systems portfolios, identify equipment approaching the end of its useful life, identify legacy systems, identify emerging or innovative technology/systems, support developing medical equipment and clinical systems strategic plans.</li>
</ul>
Internal Operations:
<ul>
<li>Regulatory Compliance - Ensure compliance with VA and regulatory standards pertaining to medical equipment and clinical systems including those from VHA's Office of Healthcare Technology Management (HTM), The Joint Commission (TJC), National Fire Protection Association (NFPA), Food and Drug Administration (FDA), and others.</li>
<li>Data Analytics Support – Perform ad-hoc analytical SQL queries, develop PowerBI reports, and develop SQL Server Reporting Services (SSRS) reports to support data analytics and data reporting for Biomedical Engineering operations. Support ASP.NET MVC web development, troubleshoot analytics applications, and provide bug fixes to reports and web applications to assist national Biomedical Engineering data analytics initiatives. Support in this area requires proficiencies in Microsoft PowerBI, Microsoft SQL Server, Reporting Services (SSRS), ASP.NET MVC framework, and Web App Development and could require proficiencies in, C#, T-SQL, HTML and JavaScript, ETL, Development using Microsoft SQL Server Data Tools (SSDT), and Internet Information Services (IIS).</li>
</ul>
Job Details
Work for a leader in government contracting! PS360 offers terrific benefits:
· Excellent Compensation &amp; Exceptional Comprehensive Benefits
· Paid Vacation, Paid Sick Days, and 11 Paid Federal Holidays
· Medical/Dental/Vision and Health Savings Account available
· Company Paid STD, LTD and Life Insurance
· Annual CME Stipend and License/Certification Reimbursement
· 401K
 
About ProSource360 Consulting: ProSource360 is a Small Disadvantaged Business (SDB) and HUBZone firm that offers Information Technology (IT) Support Services, Management Consulting, and Healthcare focused services to federal, state, and local government agencies as well as selected healthcare organizations. ProSource360 is dedicated to maintaining the highest standards in the quality of our team members and our work, in a cost-efficient manner. We help organizations achieve quantifiable solutions to their strategic imperatives. We have an innovative culture and provide excellent compensation and benefits to our full-time employees. 
 
Work Schedule:
Day Shift, Monday - Friday between the hours of 7:00am - 4:00pm
No Weekends, No Call
Requirements:
Qualifications
<ul>
<li>Bachelor’s degree or higher in computers or Engineering or Certification as a Clinical Engineer (CCE)</li>
<li>Demonstrated knowledge of concepts related to computer based medical systems, networking protocols, and information security as it applies to medical technology within VHA</li>
<li>Demonstrated competency in the ability to conduct a medical equipment management program that is compliant with applicable healthcare standards and regulatory agencies; ability to develop a curriculum for a continuing education program that address the safe and effective use of medical technology; ability to manage a recall and safety alert program for medical devices, including medical device hazard investigations, to assure compliance with patient safety goals, SMDA, and TJC requirements; ability to conduct capital asset and infrastructure planning for medical equipment spanning initial concept, installation, and effective implementation of complex medical equipment; ability to function as the subject matter expert in the field of biomedical engineering, directly supporting specialized clinical technology, including service, system administration, training, quality assurance, and life-cycle management; ability to effectively advise clinical and administrative staff on medical technology, including existing and emerging technology, which addresses viability, long-term suitability, compatibility, and/or safety; to apply project management principles to deployment of medical equipment and health information technologies</li>
<li>Demonstrated skill in communicating and working collaboratively with key stakeholders, including technical and professional staff at various levels of the organization.</li>
<li>Understanding of regulatory agencies’ requirements, industry regulatory requirements and International Standard Organization standards</li>
<li>Valid Driver's License: A valid driver’s license is required for the position to obtain authorization to drive a government motor vehicle to service medical equipment that may be in other buildings</li>
<li>Security: Must possess ability to pass a government background check/security clearance.</li>
</ul>
ProSource360 Consulting Services, Inc. is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

Network Engineer- Healthcare (1 Yr Contract)

<h3>Job Description</h3>
Job Description
(ID: 2025-0920)
 
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Senior Software Engineer, Health Data Interoperability to join our vibrant team at the National Institutes of Health (NIH) supporting the National Center for Advancing Translational Sciences (NCATS) located in Rockville, MD.
Benefits We Offer:
<ul>
<li>100% Medical, Dental &amp; Vision Coverage for Employees</li>
<li>Paid Time Off and Paid Holidays</li>
<li>401K match up to 5%</li>
<li>Educational Benefits for Career Growth</li>
<li>Employee Referral Bonus</li>
<li>Flexible Spending Accounts:
<ul>
<li>Healthcare (FSA)</li>
<li>Parking Reimbursement Account (PRK)</li>
<li>Dependent Care Assistant Program (DCAP)</li>
<li>Transportation Reimbursement Account (TRN)</li>
</ul>
</li>
</ul>
Overview
Join the team at the forefront of revolutionizing medical research in the United States. We are building and maintaining the foundational infrastructure of the National Clinical Cohort Collaborative (N3C), the nation's largest and most significant public repository of harmonized electronic health record (EHR) data. 
We believe that the future of health research depends on elegant, robust, and scalable software. Brittle, hand-coded scripts and opaque processes can't solve the challenges of petabyte-scale clinical data. We need engineers who can think in systems, build powerful abstractions, and create the tools that will accelerate discovery for thousands of researchers nationwide.
The Opportunity: Your Impact
We are seeking an exceptional Senior Software Engineer to design and build the core libraries and engines that power our data interoperability and harmonization efforts. Your primary challenge will be to tame the complexity of heterogeneous health data. You won't be writing one-off ETL scripts. You will be creating the declarative frameworks, data model transformers, and terminology mapping engines that make moving data between standards like OMOP and FHIR a systematic, reproducible, and even beautiful process
This is a role for a true craftsman. Someone who gets excited about API design, compiler theory, and building developer-centric tools. You will have the autonomy to architect foundational components from the ground up, influencing the technical direction of a project with national significance. If you want to build software that empowers scientists and enables discoveries that were previously impossible, this is your opportunity.
What You'll Do:
<ul>
<li>Architect Core Interoperability Libraries: Design, build, and maintain high-performance libraries in Python (and potentially Rust) for mapping, transforming, and validating massive clinical datasets.</li>
<li>Develop Declarative Data Mapping Engines: Create sophisticated tools that allow domain experts to define complex data transformations using simple, clear, domain-specific languages (DSLs), separating the "what" from the "how."</li>
<li>Build Advanced Terminology Services: Engineer libraries that handle the complex logic of mapping clinical terminologies, normalizing units of measure, and ensuring semantic consistency across disparate datasets.</li>
<li>Create Robust Data Model Abstractions: Develop strongly-typed data access layers and handlers that abstract away the underlying storage (e.g., SQL databases, Parquet files, JSON documents), presenting a unified interface for data manipulation.</li>
<li>Champion Software Engineering Excellence: Drive best practices in API design, testing, documentation, and tooling. You will produce libraries that are not only powerful but also a pleasure for other developers to use.</li>
<li>Collaborate and Innovate: Work closely with data engineers, informaticians, and scientists to understand their deepest challenges and create the foundational tools they need to succeed.</li>
</ul>
What You'll Bring (Required Qualifications):
<ul>
<li>A profound passion for building elegant, high-quality developer tools and libraries.</li>
<li>Bachelor's or Master's degree in Computer Science or a related engineering field with 8+ years of professional software development experience.</li>
<li>Expert-level proficiency in Python, with deep knowledge of its object model, type system, and performance characteristics. You write clean, idiomatic, and highly testable code.</li>
<li>Proven experience designing and building libraries or frameworks for other developers. Your resume shows a history of creating successful abstractions.</li>
<li>A strong foundation in computer science fundamentals, including data structures, algorithms, and compiler/interpreter design (e.g., experience with parsing, abstract syntax trees, etc.).</li>
<li>Experience with modern software development practices: version control (Git), CI/CD, comprehensive unit testing, and meticulous documentation.</li>
</ul>
What Sets You Apart (Preferred Qualifications):
<ul>
<li>Experience with Rust. A strong interest or professional experience in Rust is highly desirable for performance-critical components.</li>
<li>Deep experience with healthcare data and a clear understanding of the challenges posed by standards like OMOP, FHIR, and other Common Data Models.</li>
<li>Experience building and working with Domain-Specific Languages (DSLs).</li>
<li>Expertise in building high-performance data processing systems and a keen eye for optimization.</li>
<li>Contributions to open-source software libraries and frameworks.</li>
</ul>
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: <a href="mailto:careers@axleinfo.com" target="_blank">careers@axleinfo.com</a>
This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location.
#IND
Salary Range$130,000—$169,000 USD

Senior Software Engineer, Health Data Interoperability

<h3>Job Description</h3>
Job Description
Job Description:
The Electrical Tech Support Engineer will provide in-house and on-site customer service, training, and support on all medical, hospital and surgical equipment.
Responsibilities:
- Primary responsibilities include supporting Customers and Dealer Network by way of providing training, troubleshooting, repair, and preventive maintenance.
Specifically:
- Support Dealer Network and Customers by helping them to diagnose problems and offer options for resolution.
- Communicate and coordinate repair activities/training with Suppliers.
- Prepare and maintain accurate service records/transactions of work performed.
- Represent the company in a service role and take responsibility for customer satisfaction. Increase customers’ loyalty by professionally communicating with them.
- Respond to customers’ requests promptly and provide solutions within the entitled response time.
- Support the Sales Team with Product Training.
- Assist Sales Team with service and training of equipment to Customers and Dealer Network in-house or at customer sites.
Required skills:
- Bachelor’s degree or equivalent in Electrical, Electronic, or Biomedical Engineering.
- At least two years’ experience as a service/support person resolving issues.
- Excellent technical troubleshooting/repair skills for medical equipment.
- Strong customer services skills including strong verbal, written and interpersonal communication.
- Self-motivated. Must have ability to work independently.
- Willing to travel overseas.
- Bilingual English/Spanish (Mandatory).
- Must reside in South Florida. Not applicable to international candidates.
- The company reserves the right to add or change duties at any time.

Electronics Tech Support Engineer (Medical Devices)

<h3>Job Description</h3>
Job Description
Are you an innovative Field Service Engineer with a passion for cutting-edge technology? Join Sightpath Medical, the premier provider of mobile cataract and LASIK services in the U.S. You’ll have the unique opportunity to work with advanced ophthalmic equipment while supporting top surgeons in a fast-paced and rewarding environment. Whether you’re an entry-level candidate or bring years of experience, we offer knowledge, collaboration, and a shared commitment to excellence.
 
Why Sightpath Medical?
<ul>
<li>Comprehensive Training: Gain hands-on experience with the latest in ophthalmic laser technology. We provide all the training you need to excel in the field.</li>
<li>Independent Work Environment: You’ll have the autonomy to manage your work effectively while being part of an expert team.</li>
<li>Travel: You will have ownership of an assigned territory you will manage with a company provided vehicle and equipment. Every day is different. You will move from facility to facility providing expert service to our customers.</li>
<li>Work-life balance: With 8-10 case days per month, enjoy flexibility on non-case days when working from home or while traveling.</li>
<li>Medical benefits including health, dental, vision, short/long-term disability, and health savings account.</li>
<li>401(k) plan with employer contribution.</li>
<li>Health and Wellness Program to support your well-being.</li>
</ul>
 
What You’ll Do:
<ul>
<li>Technical Expertise: Install, de-install, calibrate, and operate transportable lasers and related equipment at customer sites.</li>
<li>Surgical Support: Ensure all equipment is programmed and calibrated to surgeon specifications prior to surgeries. You will also support the Surgeons during surgery to ensure customer satisfaction.</li>
<li>Preventative Maintenance: Perform routine maintenance and repairs to maximize equipment performance and minimize downtime.</li>
<li>Troubleshooting: Diagnose and resolve equipment issues efficiently, ensuring seamless surgical procedures.</li>
<li>Sterile Technique and Clinical: Adhere to sterile techniques during surgeries to ensure patient safety. Comprehensive training will be provided for all clinical aspects and requirements.</li>
<li>Manual Labor: Willing and able to assist with equipment setup and transport.</li>
<li>Other Duties: Flexibility to take on additional responsibilities as required.</li>
</ul>
 
Who We’re Looking For:
<ul>
<li>Technical Degree: Degree in Laser Electro-optics, Biomedical Equipment Technology, Electronics, or a similar field; military training in related fields is also acceptable.</li>
<li>Hands-On Experience: Proficiency with basic electronics and test equipment. Experience with laser systems is a plus.</li>
<li>Adaptable and Travel-Ready: Comfortable with driving to various locations in assigned territory and staying overnight when needed. All travel expenses are covered (hotel stays, gas for company vehicle, and meal allowances while traveling).</li>
<li>Driving Record: Able to produce a valid driver's license and pass a Motor Vehicle Report (MVR)/ driving record.</li>
<li>Excellent Communicator: Able to build strong relationships quickly with surgeons and their teams.</li>
<li>Self-assured: Able to thrive in high-pressure environments with confidence and professionalism.</li>
<li>Organized and Detail-Oriented: Skilled at managing equipment and completing administrative tasks required to support assigned territory.</li>
<li>Physical Demands: Ability to lift up to 100 lbs. and stand for extended periods.</li>
</ul>
 
Relocation Assistance:
We offer relocation allowances for qualified candidates who may need to move to join our team.&nbsp;
 
Compensation Range:
<ul>
<li>$65,000 - $80,000 annually with bonus eligibility</li>
<li>Company credit card provided for company use including: hotel stays, gas for company vehicle, maintenance for vehicle, meal allowance (when an overnight stay is required for coverage purposes), etc.</li>
</ul>
SIGHTPATH is an equal opportunity employer. In accordance with applicable law, we prohibit discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age (40 and over), national origin or ancestry, physical or mental disability, genetic information or any other consideration protected by federal, state or local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee, including supervisors and coworkers.
 
PM25
 
Compensation details: 60000-75000 Yearly Salary
 
PI6e4e3125bf84-25405-38196172

Laser Engineer III

<h3>Job Description</h3>
Job Description
ABOUT ORGANOX:
OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.
Position Summary
The Product Quality Engineering team at OrganOx is a technical quality engineering team responsible for monitoring, understanding, and improving product performance of the OrganOx Metra, a Class III medical device. The Product Quality Engineering team works closely with Product Sustaining Engineering and Contracted Suppliers to set in place quality control and management processes for externally built products and componentry, including sterilization and microbiology, supplier management, and contract manufacturing processes. 
The Product Quality Engineer will have strong hands-on technical skills with an ability to analyze product quality issues and work cross-functionally to solve problems related to product quality. 
The successful candidate is collaborative, has excellent communication and problem-solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer. 
Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.
This is a flexible, on-site role in our Madison, NJ office.
Major Responsibilities 
Under direction from the Senior Product Quality Engineer and Senior Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for the following: 
<ul>
<li>Lead root-cause investigations in response to customer complaints </li>
<li>Support hands-on analyses of returned products to identify root causes of failures</li>
</ul>
· Support development of investigation criteria and test methods to properly diagnose and root cause field failures 
<ul>
<li>Analyze and trend on product performance data to provide recommendations for product improvements </li>
<li>Raise Supplier Corrective Action Reports (SCARs) in response to product performance trends. Support timely closure of SCARs. </li>
<li>Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures. </li>
<li>Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts </li>
</ul>
· Support CAPAs, Escalations, and engineering investigations in response to field quality issues. 
<ul>
<li>Participate in the development and review of engineering change orders that impact product quality activities </li>
<li>Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations.</li>
<li>Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.</li>
</ul>
Requirements
Skills and Experience
<ul>
<li>Experience investigating and resolving SCARS and CAPAs </li>
<li>Strong experience with statistical analysis of data; Experience with Minitab preferred </li>
<li>Experience with Six Sigma principles preferred</li>
<li>Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills</li>
<li>A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations</li>
<li>Strong focus on meeting customer needs</li>
<li> Proven ability to work cross functional and within global teams, fostering a culture of high collaboration</li>
<li>Ability to be self-driven and solve complex problems independently. Committed to upholding OrganOx values in daily work and decision-making </li>
<li>Experience in driving a global quality mindset across teams and geographies</li>
<li>Demonstrated strong attention to detail and “do it right the first time” attitude</li>
</ul>
Qualifications 
<ul>
<li>Bachelor’s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience is required</li>
</ul>
· 1-4 years of related hands-on engineering experience in Medical Devices, Pharmaceuticals or other regulated industry is required
<ul>
<li>Excellent technical report writing skills are required</li>
<li>Strong Root Cause Analysis, Design of Experiments, and Test Method Development experience as related to complaint investigations is required</li>
<li>Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.) is required</li>
<li>Prior experience performing complaint investigations preferred </li>
<li>A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives is highly preferred</li>
<li>Knowledge of electro-mechanical troubleshooting techniques is preferred</li>
<li>Familiarity with ISO14971 and associated Risk Management Processes is a plus</li>
<li>Six Sigma Green Belt or Black Belt Certification preferred </li>
<li>Ability to travel 10-20% (domestically and internationally)</li>
</ul>
#LI-Hybrid
A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate. 
Benefits
The Pay Range for this position is $105,000 - $115,000 annually, with a 10% target annual bonus and benefits.
At OrganOx, We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Product Quality Engineer

<h3>Job Description</h3>
Job DescriptionDEKA Research and Development, located in Manchester, NH, has an immediate opening for a Verification and Validation Test Engineer&nbsp;to work in a dynamic medical device R&amp;D environment. Test Engineering is a high-visibility role with a significant, direct impact on the success of the project. How you will make an impact as a&nbsp;Verification and Validation Test Engineer:
<ul>
<li>Developing and writing test procedures&nbsp;assessing end-to-end performance and reliability of user interfaces and hardware</li>
<li>Understanding device design and core technologies in order to inform test method development</li>
<li>Determining test coverage for revisions to design</li>
<li>Creating and evaluating test fixtures if needed for product design verification</li>
<li>Contributing to design failure investigations that may impact Risk Assessments, Hazard Analyses, and FMEAs</li>
<li>Contributing toward&nbsp;regulatory and agency submissions</li>
<li>Authoring Test Summaries and other documents</li>
</ul>
To be successful in this role as a Verification and Validation Test Engineer, you will need the following skills and experience:
<ul>
<li>Must have a BS in Physics, Biology, Electrical, Mechanical, or Biomedical Engineering.</li>
<li>Experience with research, development, and product testing</li>
<li>Experience writing procedures for others to follow</li>
<li>Experience with data and failure analysis</li>
<li>Broad measurement instrument knowledge</li>
<li>Knowledge and deep understanding of engineering fundamentals</li>
<li>Demonstrated problem solving ability and techniques</li>
<li>Ability to work as part of an interdisciplinary team</li>
<li>Self-motivated and able to self-prioritize</li>
<li>Ability to clearly explain objectives</li>
<li>Must be detail oriented and have excellent verbal and written communication skills</li>
<li>Experience in medical devices, knowledge of FDA&nbsp;Quality System Regulations (QSRs) and/or ISO&nbsp;13485, and other medical device industry experience preferred</li>
</ul>
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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