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job_organization_name

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city

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<h3>Job Description</h3>
Job Description
Company Information Our client is an industry-leading laboratory equipment manufacturer best known for its high-quality centrifuges and incubators used in clinical, blood processing, and research laboratories. Additionally , offering special centrifuges and other equipment for integration with laboratory automation systems.
Role Overview&nbsp; The Field Service Engineer will carry out repairs, calibrations, validations on centrifuges, incubators and other proprietary/lab equipment. Travel throughout St. Louis, Missouri, extending to Chicago in order to meet customer product needs is essential; whilst maintaing an excellent level of customer satisfaction on sites that are assigned. The FSE must be comfortable with flights to ensure that services are met within a timely fashion. · Carry out calibrations, validations and repairs on centrifuges, incubators, and other proprietary products/lab equipment. · Identify, Troubleshoot and Repair customer equipment in a cost-effective manner · Military, clinical engineering, biomedical, mechanical experience in the field · Maintain an excellent level of customer satisfaction on sites that are assigned to you
Person specification · Field service experience with electrical/electronic schematics and/or military electronics · Strong diagnostic skills, within the bio-medical field/clinical engineering/military bio-medical repair · Ability to utilize electrical and mechanical testing equipment · Attentive to detail · Prioritization abilities to evaluate demands daily · Professional demeanour with customers · Clear communication skills · Military, clinical engineering, biomedical, mechanical experience in the field · (Preferred) Experience with small electric testing tools DVM, ammeters, oscilloscopes, etc
Company DescriptionZenopa is a service organisation that provides flexible, rapid and effective recruitment solutions to our clients. We specialise in the commercial side of the healthcare industry, and recruit for various markets including, Pharmaceutical, Medical, Scientific, Animal Health, Dental, Engineering, Consumer Health, and Medical Communications. Zenopa has an excellent reputation spanning over 25 years, being awarded 'Great Place to Work' four years in a row, and is one of the leading recruitment agencies. Based in High Wycombe, Buckinghamshire and Charlotte, NC the company has demonstrated fantastic growth over the past 10 years. 
<h3>Company Description</h3>
Zenopa is a service organisation that provides flexible, rapid and effective recruitment solutions to our clients. We specialise in the commercial side of the healthcare industry, and recruit for various markets including, Pharmaceutical, Medical, Scientific, Animal Health, Dental, Engineering, Consumer Health, and Medical Communications. Zenopa has an excellent reputation spanning over 25 years, being awarded 'Great Place to Work' four years in a row, and is one of the leading recruitment agencies. Based in High Wycombe, Buckinghamshire and Charlotte, NC the company has demonstrated fantastic growth over the past 10 years.

Field Service Engineer

<h3>Job Description</h3>
Job DescriptionDescription:
This systems engineer role provides an opportunity to work with a highly cross-functional team including scientists/engineers, clinical/regulatory and marketing staff to contribute towards successful ophthalmic medical products. The nature of projects may range from new product development, sustaining and improving existing products. The successful candidate will provide technical leadership in systems engineering related areas including system requirements specification, system architecture and design, and system verification and validation. The systems engineer also assumes the following responsibilities as required: support product sustaining, improve product reliability and quality, and conduct testing to meet medical device standards. Strong grasp on the fundamentals of optical imaging system design, pilot production experience, team-player with effective communication skills, open-mindedness to new ideas and methodical problem-solving skills are some of the key attributes that are expected from the position. Senior or Staff title will depend on the candidate’s experience and qualifications.
 
Essential Responsibilities
<ul>
<li>Participate in new product development and work with a highly cross-functional team through various stages of product development.</li>
<li>Plan and conduct in-depth reviews, testing and verifications/validation of product features. Conduct design transfer to manufacturing team.</li>
<li>Perform trade-off analysis of technology, systems architecture, and design alternatives through simulation, test, and measurements.</li>
<li>Early identification of technical risks and developing a plan for addressing these issues.</li>
<li>Provide technical leadership in qualifying new parts/modules and confirming system performances to support product sustaining.</li>
<li>Lead product troubleshooting to improve product quality/reliability.</li>
<li>Identify and build improvements or enhancements to existing products.</li>
<li>Other duties as assigned.</li>
</ul>
Requirements:
<ul>
<li>PhD in optics, biomedical instrumentation, electrical engineering, physics, bioengineering or related field plus 3 years of relevant work experience; or MS in related engineering field plus 5 years of relevant work experience.</li>
<li>Track record of delivering complex medical devices to market as systems engineer and good documentation with the compliance to medical device design control standard, e.g. ISO 13485 and FDA 21 CFR 820.30.</li>
<li>Hands-on experience of developing a new medical product through various stages of product development process.</li>
<li>Familiar with system safety and EMC testing (IEC 60601-1 and IEC 60601-1-2), environmental testing, and reliability-related testing etc.</li>
<li>Strong understanding of integrated optical imaging systems involving opto-mechanics, electronics, basic image processing and related sub-systems and technologies.</li>
<li>Strong problem solving and trouble shooting skills.</li>
<li>A self-motivated team player who is adaptable and comfortable working in a dynamic, high-paced environment. </li>
<li>Experience in developing imaging devices and products that required synchronized data collection and instrument control.</li>
<li>Familiar with ISO 15004 is a plus.</li>
<li>Experience in pilot production process for medical devices.</li>
<li>Experience in collaborating with marketing, doctors and clinical researchers.</li>
<li>Mathematical modeling skills using MATLAB or other tools</li>
</ul>

Staff System Engineer

<h3>Job Description</h3>
Job Description
Empower, Innovate, Impact! At Team A-TEK, we EMPOWER people to drive INNOVATION that IMPACTS mission!
A-TEK operates at the intersection of mission and innovation by applying our deep domain expertise across the federal markets. Embracing our digital-first strategy, A-TEK provides enhanced capabilities in application development, digital transformation, enterprise IT, and scientific services. Our solutions are designed to modernize, automate, secure, protect, and enhance the operations of our federal clients, ensuring they stay ahead in a rapidly evolving digital landscape.
Our work is fueled by a passion to serve our clients' needs and to protect the safety and welfare of Americans. That passion shapes how we nurture our most valuable asset – Our Employees. A-TEK actively cultivates the talent that drives our success and fosters a creative, challenging, and mission-driven work environment for current and future employees.
Are you a strategic thinker and hands-on technologist passionate about building and maintaining high-performance computing environments that enable groundbreaking research? A-TEK is seeking a Senior Systems Engineer to join our dynamic and mission-driven team. In this role, you will play a pivotal part in architecting, deploying, and optimizing complex systems that support advanced scientific and technical research initiatives. Working closely with researchers, data scientists, and technical teams, you will ensure the robustness, scalability, and security of infrastructure is critical to solving real-world challenges.
This position is remote. Ability to obtain and retain a public trust clearance is required. We are currently not accepting external sponsorship candidates.
As a member of A-TEK's technology team, you will play a pivotal role in architecting, maintaining, and enhancing large-scale infrastructure solutions that support our client's scientific and research platforms, including PubMed, GenBank, BLAST, and more. This role requires a blend of strong systems engineering expertise, DevSecOps experience, and the ability to collaborate across multidisciplinary teams in a high-impact, fast-paced environment.
Key Responsibilities:
<ul>
<li>Design, implement, and manage scalable, secure, and high-performance computing systems and environments.</li>
<li>Lead system architecture planning and infrastructure modernization efforts to support growing biomedical data needs.</li>
<li>Support continuous integration and deployment (CI/CD) pipelines across hybrid environments (on-premises and cloud).</li>
<li>Collaborate with bioinformatics specialists, software engineers, and data scientists to ensure infrastructure aligns with research workflows.</li>
<li>Monitor and optimize system performance, availability, and capacity planning.</li>
<li>Ensure system security and compliance with NIH/NCBI standards, including vulnerability assessments and patch management.</li>
<li>Lead troubleshooting of complex issues across a variety of systems and platforms.</li>
<li>Document system architecture, configuration, and processes clearly and thoroughly.</li>
</ul>
Required Qualifications:
<ul>
<li>Bachelor's degree in Computer Science, Engineering, or a related field (Master's preferred).</li>
<li>7+ years of experience in systems engineering, infrastructure, or DevSecOps roles.</li>
<li>Strong experience with Linux systems administration (AlmaLinux).</li>
<li>Experience with streaming technologies (Kafka)</li>
<li>Proficiency with scripting and automation tools (e.g., Bash, Python, Java, Ansible, Terraform).</li>
<li>Experience with cloud platforms, AWS, Azure, and GCP.</li>
<li>Familiarity with containerization technologies such as Docker and orchestration tools like Kubernetes.</li>
<li>Strong understanding of networking, storage, and high-availability architectures.</li>
<li>Experience working in agile environments and supporting DevSecOps practices.</li>
</ul>
Preferred Qualifications
<ul>
<li>Experience supporting NIH platforms or working in bioinformatics/scientific computing environments.</li>
<li>Understanding of data pipeline technologies and HPC cluster environments.</li>
<li>Familiarity with NIH IT security policies and FISMA compliance.</li>
<li>AWS GCP, or Azure certification</li>
<li>Strong interpersonal and communication skills; ability to interface effectively with technical and non-technical stakeholders.</li>
</ul>
A-TEK, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or status as a qualified individual with a disability, or Vietnam era or other protected Veteran status.

Senior Systems Engineer

<h3>Job Description</h3>
Job Description
Steel Point Solutions is an amazing SBA Certified (8a), HUBZone, Small Disadvantaged Business (SDB) and a Woman Owned Small Business (WOSB) company. Established in 2013 with a vision of offering world class, integrated business solutions for all levels of Government and commercial enterprises. We are represented by a team of talented and qualified professionals who know how essential efficient, cost-effective integrated solutions are to your organization's success. Leveraging these resources, we strive daily to lead the industry in program management and service delivery. 
Role Summary
The System Engineer applies systems engineering principles throughout the systems life cycle phases: Concept, Development, Production, Utilization, Support, and Retirement. Interacts with the Government regarding Systems Engineering technical considerations and for associated problems, issues or conflicts. Communicate with other program personnel, government overseers, and senior executives. Responsible for the technical integrity, quality, and completeness of work performed and deliverables associated with one or more of the 25 process areas defined by ISO/IEC15288: 
<ul>
<li>Technical Process Area - Stakeholder Requirements Definition, Requirements Analysis, Architectural Design, Implementation, Integration, Verification, Transition, Validation, Operation, Maintenance, and Disposal</li>
<li>Project Process Area - Project Planning, Project Assessment and Control, Decision Management, Risk Management, Configuration Management, Information Management, and Measurement</li>
<li>Enterprise (Organizational Project-Enabling) Process Area - Project Portfolio Management, Infrastructure Management, Lifecycle Model Management, Human Resource Management, and Quality Management </li>
<li>Agreement Process Area - Acquisition and Supply.</li>
</ul>
Key Responsibilities 
The System Engineer shall possess the following capabilities:
<ul>
<li>Perform systems engineering activities and assist in the preparation of a work product in Technical Process Areas associated with the ISO/IEC 15288.</li>
<li>Perform systems engineering activities and assist in the preparation of multiple work products in Project and/or Technical Process Areas associated with any of the ISO/IEC 15288 processes.</li>
<li>Assist in performing systems engineering activities in the ISO/IEC 15288 Agreement or Enterprise Process Areas.</li>
<li>Perform analysis of technical alternatives for a project and make preliminary recommendations.</li>
<li>Develop and deliver a work product in any of the ISO/IEC 15288 Process Areas.</li>
<li>Perform systems engineering activities and develop and deliver work products of either the ISO/IEC 15288 Agreement or Enterprise Process Areas.</li>
<li>Independently analyze and recommend alternatives for elements of project's technical design.</li>
<li>Perform systems engineering activities and develop and deliver work products in each of the ISO/IEC 15288 Project and Technical Process Areas.</li>
<li>Supervise or coordinate the work of other contractor engineers or technicians on a project.</li>
<li>Analyze and propose appropriate engineering standards and processes for a project.</li>
<li>Assist in conducting an evaluation to determine its suitability for project implementation.</li>
<li>Assist in developing a new or innovative approach to a technical or engineering issue.</li>
<li>Brief stakeholders and present the status on all technical aspects of their project.</li>
<li>Independently make decisions regarding engineering issues and methodology for a project.</li>
<li>Approve delivery of work products of multiple Processes Areas defined in the ISO/IEC 15288.</li>
<li>Lead contractor systems engineering activities for a project to include supervising the work of the project engineering staff and technicians.</li>
</ul>
Required Qualifications
<ul>
<li>High School Diploma or GED plus nineteen (19) years of general systems engineering experience</li>
<li>Bachelor's degree in Aeronautics, Biomedical, Chemical, Civil, Computer, Electrical, Environmental, Mechanical, Nuclear, Software, Systems, Engineering Management or a related discipline plus fifteen (15) years of systems engineering experience</li>
<li>Master's degree in Aeronautics, Biomedical, Chemical, Civil, Computer, Electrical, Environmental, Mechanical, Nuclear, Software, Systems, Engineering Management or a related discipline plus thirteen (13) years of systems engineering experience.</li>
<li>PhD in Aeronautics, Biomedical, Chemical, Civil, Computer, Electrical, Environmental, Mechanical, Nuclear, Software, Systems, Engineering Management or a related discipline plus thirteen (13) years of systems engineering experience.</li>
</ul>
Candidates from Historically Underutilized Business Zones (HUBZone) are strongly encouraged to apply. To determine whether you reside in a HUBZone, visit: <a href="https://maps.certify.sba.gov/hubzone/map" target="_blank">https://maps.certify.sba.gov/hubzone/map</a>.
The salary range represents a general guideline; however, Steel Point Solutions considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions.
Salary Range$85,000—$200,000 USD
Steel Point offers a comprehensive benefits package for eligible full-time positions, including medical, dental, vision, life insurance, short- and long-term disability, 401K with company match, critical care voluntary insurance, flexible paid time off, paid holidays and opportunities for professional development reimbursement. Join us to enjoy competitive compensation and a full range of benefits designed to support your well-being and work-life balance. 
The salary range represents a general guideline; however, Steel Point Solutions considers a number of factors when determining base salary offers such as the scope and responsibilities of the position and the candidate's experience, education, skills and current market conditions.
Salary Range$85,000—$200,000 USD

System Engineer Level 5

<h3>Job Description</h3>
Job Description
Our client, a&nbsp;Global Medical Device Manufacture&nbsp;has an immediate opening for a&nbsp;Quality Assurance Engineer&nbsp;for a&nbsp;12 Month Contract opportunity. Our client offers results-driven people a place where they can make a difference - every day! &nbsp;You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. &nbsp;
Position Description

Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.
MAJOR DUTIES/RESPONSIBILITIES:
<ul>
<li>Collaborates with design division and/or legal manufacturer representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.&nbsp;</li>
<li>Collaborates with 3PL partners regarding physical containment and final disposition of Material Review Board product.</li>
<li>Provides oversight and assistance in NC &amp; CAPA.</li>
<li>Prepare and implement programs and processes to ensure compliance with the company's high quality standards.&nbsp;</li>
<li>Experience in medical device manufacturing and the FDA QSR are preferred.&nbsp;</li>
<li>WORKING CONDITIONS
<ul>
<li>Fast-paced office environment.&nbsp;</li>
<li>Medical Device, highly regulated environment.&nbsp;</li>
<li>Mission-oriented culture, energized by the knowledge that our products save lives every day, and our work here has a very material impact on the delivery of healthcare around the world.&nbsp;</li>
</ul>
</li>
</ul>
REQUIREMENTS
<ul>
<li>Bachelor's Degree in applicable engineering discipline preferred: Biomedical, Process or Mechanical Engineering</li>
<li>Minimum of 3-5 years in a quality role for a medical device company: &nbsp;this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment.&nbsp;</li>
<li>MDR Experience a must.&nbsp;</li>
<li>Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma) highly desirable&nbsp;</li>
<li>Excellent verbal, written and interpersonal communication skills&nbsp;</li>
<li>Excellent problem solving and analytical skills&nbsp;</li>
<li>Excellent technical writing skills&nbsp;</li>
<li>High level of attention to detail and organization&nbsp;</li>
<li>Ability to multi-task and work independently&nbsp;</li>
<li>Ability to participate in cross-functional teams&nbsp;</li>
<li>Ability to read and interpret engineering drawings and other technical specifications preferred&nbsp;</li>
<li>Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics)&nbsp;</li>
</ul>
Company DescriptionWhether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management. Benefits: 401(k) matching Comprehensive dental, vision, and health insurance Flexible schedule options Health savings account Life insurance Paid time off Professional development assistance Employee assistance and discount programs Referral program Retirement plan Tuition reimbursement iMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential. Experience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference! Contact us today to learn more: *** Grand Rapids, Michigan: 616.254.8586 *** Tampa, Florida: 813.463.8850 *** <a href="http://www.impactbusinessgroup.com" target="_blank">www.impactbusinessgroup.com</a> *** Chat with us live: <a href="https://lc.chat/now/8608604/" target="_blank">https://lc.chat/now/8608604/</a> 
<h3>Company Description</h3>
Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.\r\n\r\nBenefits:\r\n401(k) matching\r\nComprehensive dental, vision, and health insurance\r\nFlexible schedule options\r\nHealth savings account\r\nLife insurance\r\nPaid time off\r\nProfessional development assistance\r\nEmployee assistance and discount programs\r\nReferral program\r\nRetirement plan\r\nTuition reimbursement\r\n\r\niMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential. \r\n\r\nExperience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!\r\n\r\nContact us today to learn more:\r\n*** Grand Rapids, Michigan: 616.254.8586\r\n*** Tampa, Florida: 813.463.8850\r\n*** <a href="http://www.impactbusinessgroup.com" target="_blank">www.impactbusinessgroup.com</a>\r\n*** Chat with us live: <a href="https://lc.chat/now/8608604/" target="_blank">https://lc.chat/now/8608604/</a>

Quality Engineer - 26223

<h3>Job Description</h3>
Job DescriptionBridgeMed Solutions, Inc is seeking a Mechanical Engineer. Training will be provided. &nbsp; &nbsp; Are you passionate about pioneering medical innovations? Join our dynamic team at BridgeMed Solutions, where we're revolutionizing healthcare through cutting-edge technology. We are an Irvine-based Contract Manufacturing Organization that is ISO and FDA certified. We are a privately owned company that specializes in tissue heart valve technology. We additionally custom produce transcatheter valves for various clients. Embrace the opportunity to make a meaningful impact on patient care while collaborating with talented professionals in a fast-paced startup environment. Apply now and be part of our journey towards transforming lives. &nbsp; Job Title: Mechanical Engineer Experience: 1-3 of ME Professional Experience required. Experience in medical device is a plus.&nbsp; Location: Local candidates only&nbsp; Job Type: Full Time, 100% In-House Salary: $20-$28 DOE (Non-Exempt) Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage, Free Lunch Fridays, Professional Development Opportunities Principal Duties and Responsibilities 
<ul>
<li>Lead and manage engineering projects from concept through to prototype and market release, ensuring alignment with regulatory requirements (FDA, ISO).</li>
<li>Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to develop project plans, schedules, and risk assessments.</li>
<li>Develop and review technical documentation, including design specifications, test protocols, and validation reports, to support product development and regulatory submissions.</li>
<li>Oversee the execution of validation activities for new and legacy medical devices, ensuring they meet intended performance and safety standards.</li>
<li>Facilitate root cause investigations for non-conformance issues, implementing corrective actions and driving continuous improvement initiatives.</li>
<li>Project and client management is a must&nbsp;</li>
</ul>
Skills and Qualifications 
<ul>
<li>Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field).</li>
<li>1-3 of ME Professional Experience required.&nbsp;</li>
<li>Must have SOLIDWORKS EXPERIENCE</li>
<li>Proven experience in project coordinating and cross-functional team collaboration.</li>
<li>Strong analytical skills with the ability to conduct detailed assessments and develop effective solutions.</li>
<li>Excellent communication skills, both written and verbal, with the ability to present complex information clearly to stakeholders.</li>
<li>Proficient in Microsoft Office</li>
<li>Detail-oriented with strong organizational skills, capable of managing multiple projects in a fast-paced environment.</li>
</ul>

Mechanical Engineer

<h3>Job Description</h3>
Job Description
Overview

Now Hiring Quality Engineer! Location: Madison, TN Schedule: Monday–Friday | Full-Time
Who We Are:
Tri-Imaging Solutions is a leader in the service and support of medical imaging systems and devices. From installation and diagnostics to quality assurance and logistics, we provide comprehensive solutions that empower healthcare providers across the country. Our team is driven by precision, integrity, and continuous improvement—and we’re looking for professionals who thrive in a fast-paced, highly regulated environment.
What’s in It for You (Benefits):
<ul>
<li>Competitive salary based on experience</li>
<li>Medical, dental, and vision insurance</li>
<li>401(k) with company match</li>
<li>Paid time off and holidays</li>
<li>Supportive, team-oriented work culture</li>
<li>Opportunity to make a real impact in healthcare technology</li>
</ul>

Position Overview:
We are hiring a Quality Engineer to support quality assurance initiatives across manufacturing, service, and regulatory compliance. This role will be instrumental in overseeing tooling and equipment management, driving corrective actions, and leading internal audits to maintain compliance with ISO 13485 standards. The ideal candidate will be analytical, process-focused, and eager to make a lasting impact on product and process quality.
What You’ll Do:
<ul>
<li>Maintain the calibrated equipment and tools program</li>
<li>Support onboarding and qualification of new tools and equipment</li>
<li>Analyze product and process metrics to identify improvement opportunities</li>
<li>Lead risk assessments, failure analysis, and root-cause investigations</li>
<li>Plan and conduct internal audits; document findings and non-conformances</li>
<li>Develop and implement corrective/preventive actions (CAPAs)</li>
<li>Support supplier quality initiatives and nonconformance investigations</li>
<li>Create, revise, and manage work instructions and procedural documents</li>
</ul>

What You’ll Need (Requirements):
<ul>
<li>Associate’s or Bachelor’s degree in Engineering or related field (or equivalent experience)</li>
<li>2–5 years of quality engineering experience in a manufacturing environment</li>
<li>Experience with ISO 13485:2016 and/or ISO 9001:2015</li>
<li>Ability to interpret engineering drawings, specs, and schematics</li>
<li>Familiarity with measurement equipment and statistical tools</li>
<li>Experience with ERP/inventory systems and root-cause analysis</li>
<li>Internal auditor training or willingness to obtain</li>
<li>Strong communication, documentation, and organizational skills</li>
<li>Experience with medical imaging or biomedical equipment is a plus</li>
<li>Radiation safety knowledge is a plus</li>
</ul>

Quality Engineer

<h3>Job Description</h3>
Job Description
 
Job Title:
Senior Project Engineer, LifeSync Source
Department:
Engineering
Reports to:
VP of R&amp;D, Quality, &amp; Regulatory
FLSA
Exempt
SUMMARY: 
The Senior Project Engineer, LifeSync Source serves as the primary technical liaison between LifeSync’s contract manufacturing customers and the internal engineering and manufacturing teams at LifeSync’s facilities in China and Florida. This customer-centric role requires a strong technical foundation in medical systems using medical cables and a deep understanding of LifeSync’s manufacturing and design capabilities.
The Senior Project Engineer collaborates with cross-functional teams - including Sales, Project Management, R&amp;D, Manufacturing Engineering, Quality, and Regulatory Affairs - to develop and optimize product designs that meet customer requirements for performance, quality, cost, and regulatory compliance. Responsibilities span the entire product lifecycle, from new product development to sustaining engineering and line extensions.
Success in this role requires a structured, detail-oriented mindset, strong mechanical and electrical design skills, and the ability to execute multiple projects simultaneously. Prior experience in medical device product development and technical documentation is essential.
DUTIES AND RESPONSIBILITIES:
Customer Collaboration &amp; Technical Leadership
<ul>
<li>Serve as the primary technical point of contact for customers, ensuring clear communication of design, quality, and regulatory requirements.</li>
<li>Work with customers to define and document product specifications, design constraints, and verification/validation (V&amp;V) needs.</li>
<li>Facilitate customer requirements for prototypes and align on V&amp;V strategies to support regulatory submissions and product launch.</li>
<li>Assist customers with design reviews, risk management activities, and regulatory compliance requirements.</li>
<li>Provide technical expertise to support sales efforts, customer engagements, industry conferences, and exhibitions.</li>
</ul>
Product Design &amp; Development
<ul>
<li>Brainstorm and refine design solutions with customers and internal R&amp;D teams.</li>
<li>Develop mechanical and electrical designs while ensuring compliance with industry standards and best practices.</li>
<li>Conduct worst-case tolerance analyses for components and subassemblies to ensure robust designs.</li>
<li>Work with LifeSync Manufacturing Engineering and customer teams to optimize designs for manufacturability, cost efficiency, and reliability.</li>
</ul>
Risk Management &amp; Quality Compliance
<ul>
<li>Contribute to risk management activities, including risk hazard analysis, dFMEA, and pFMEA.</li>
<li>Support customer complaint investigations, including root cause analysis, and implementation of corrective actions for design, process, or supplier quality issues.</li>
<li>Participate in internal and external design reviews throughout the product development process.</li>
</ul>
Project Execution &amp; Documentation
<ul>
<li>Assist LifeSync’s project management function in developing structured project plans, including scoping, work breakdown structures, Gantt charts, risk registers, and status reports.</li>
<li>Review and contribute to test protocols and reports, ensuring alignment with industry standards and quality system requirements.</li>
</ul>
Innovation &amp; Continuous Improvement
<ul>
<li>Identify opportunities for innovation and intellectual property (IP) creation.</li>
<li>Support process improvements in design, manufacturing, and quality control.</li>
<li>Collaborate with teams to implement best practices in design for manufacturability (DFM) and design for reliability (DFR).</li>
</ul>
REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Technical Expertise &amp; Design Skills
<ul>
<li>Proficiency in technical communication, including structuring and presenting technical information for internal and external audiences.</li>
<li>Strong interpretation skills for drawings, specifications, mechanical, electrical, and material requirements.</li>
<li>Experience in CAD solid modeling, such as using SolidWorks.</li>
<li>Experience in the design and manufacture of custom molded parts, injection over-molding, and printed circuit board assemblies.</li>
<li>Proficiency in design for manufacturability (DFM) and manufacturing process development.</li>
<li>Strong technical writing skills, including preparation of design documentation, test reports, and risk management documentation.</li>
<li>Experience in project management methodologies, including work breakdown structures, risk registers, and execution status reporting.</li>
</ul>
Regulatory &amp; Compliance Knowledge
<ul>
<li>Familiarity with FDA QSR, ISO 13485, and regulatory design controls.</li>
<li>Expertise in product risk management, including risk hazard analysis, dFMEA, and pFMEA.</li>
<li>Knowledge of common medical device industry design and manufacturing standards, such as IEC 60601-1, ISO 14971, and IPC standards.</li>
</ul>
General &amp; Soft Skills
<ul>
<li>Strong problem-solving skills, with the ability to balance technical, quality, and business considerations.</li>
<li>Ability to be flexible with working hours to accommodate global time zones.</li>
<li>Excellent communication and interpersonal skills, with the ability to gain buy-in from customers and internal stakeholders.</li>
<li>Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project preferred).</li>
<li>Strong understanding of component and BOM structures within ERP systems.</li>
</ul>
SUPERVISORY RESPONSIBILITIES: N/A
EDUCATION AND/OR EXPERIENCE:
<ul>
<li>Bachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related discipline.</li>
<li>5+ years of experience in design engineering, with at least 2 years in a regulated industry (medical devices preferred).</li>
<li>2+ years of experience working directly with external customers in a technical role.</li>
</ul>
PHYSICAL DEMAND:
Physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
<ul>
<li>Stand, move, sit, talk/hear, vision, lift to ≤10 lbs. </li>
</ul>
WORK ENVIRONMENT:
Typical Office / Production Environment
TRAVEL REQUIREMENT:
<ul>
<li>Domestic: typically, once per month (or less).</li>
<li>International: typically, once per year.</li>
</ul>
 
 
 
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Senior Project Engineer

<h3>Job Description</h3>
Job Description
Company &amp; Job Overview:
Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. 
As a Staff Mechanical Engineer, you will bring deep technical expertise and leadership to our engineering team, driving innovation, ensuring compliance with regulatory standards, and contributing to the success of our projects.

Responsibilities:
<ul>
<li>Provides solutions to various issues in creative and effective ways.</li>
<li>Understands and works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. </li>
<li>Exhibits advanced wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures. </li>
<li>Leads the development of mechanical system and component designs, including planning, and cross-functional coordination.</li>
<li>Is a key stakeholder in defining project plans and helps anticipate and mitigate risks to project success.</li>
<li>Accountable to ensure product features, performance, reliability and quality are met within the cost budget and delivered on time.</li>
<li>Owns the creation and completion of hardware requirement documents.</li>
<li>Designs mechanical components, parts, assemblies and systems of significant complexity.</li>
<li>Creates component and assembly drawings including complex modeling and dimensioning.</li>
<li>Generates complete BOMs and build packages, works with manufacturing and external suppliers on fabrication and build processes ensuring design for manufacturability</li>
<li>Considers complex and dynamic tradeoffs when implementing design.</li>
<li>May lead issue resolution of advanced/complex technical issues.</li>
<li>May lead system safety, shock and vibration, shipping, environmental, biocompatibility, mechanical, fluidics and reliability testing.</li>
<li>Applies risk, failure analysis, and root cause analysis as required within the engineering discipline.</li>
<li>Works with production to ensure manufacturability and testability of mechanical designs and sub-systems.</li>
<li>Ensures all the design activities and documents meet the regulatory and QMS requirements.</li>
<li>Collaborates closely with other departments, including regulatory affairs, quality assurance, manufacturing, and marketing, and other engineering functions to ensure alignment on project objectives and priorities. </li>
<li>Communicates effectively with stakeholders at all levels of the organization to drive consensus and facilitate decision-making.</li>
<li>Responsible for leading and presenting technical documentation for system design reviews and phase gate reviews. </li>
<li>Identify opportunities for process improvements, cost reductions, or efficiency gains within the engineering function.</li>
<li>Can be given complex tasks without supervision and is responsible for the engineering function deliverables.</li>
<li>May be a technical lead for sub-system design that may include cross-functional team members. </li>
<li>Provides guidance and mentorship to junior engineers, sharing insights, best practices, and lessons learned from previous experiences.</li>
<li>Actively participants in technical issues and leads cross-functional teams for root cause investigations.</li>
</ul>
Qualifications &amp; Requirements: 
<ul>
<li>Bachelor’s degree in biomedical, electrical, mechanical, systems or software engineering.</li>
<li>Minimum 8 years of related experience or 6 years and a Master’s degree in engineering.</li>
<li>Has in depth understanding of system architecture design and is a subject matter expert in multiple system or sub-system design related core competencies.</li>
<li>Working knowledge of medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.</li>
<li>Demonstrable experience in advanced mechanical engineering principles and applications.</li>
<li>Expert in ANSI standards, material tolerancing and tolerance analysis. Experience using advanced tolerance analysis tools. Understands impact of tolerances to performance, assembly, qualification, inspection and cost.</li>
<li>Expert experience in the creation of plastic parts including injection molding and vacuum forming of complex parts. Experience in mold design, mold flow analysis and various material types, design for cost effectiveness. Experience with second operations with plastic parts including inserts, welding, bonding.</li>
<li>Expert experience in the creation of metal parts including sheet metal, die casting, investment casting, extrusion and machining. </li>
<li>Strong knowledge of structural analysis and thermal and fluid dynamics.</li>
<li>Ability to build and test prototype systems, including writing and executing verification protocols.</li>
<li>Able to conduct FEA and basic CFD analysis.</li>
<li>Experience with mechanism and component design.</li>
<li>Expert experience with solid modeling tools (Solidworks).</li>
<li>Experience with design for manufacturability including manufacturing requirements, test fixtures and systems, demonstrated ability to take designs through full product life cycle.</li>
<li>Expert knowledge of IEC60601 series standards, experience with test and troubleshooting of mechanical and thermal safety.</li>
<li>Understanding of Medical Device QMS and design control, familiar with PDM/PLM system and change control process.</li>
<li>Strong problem-solving skills and the ability to develop innovative engineering solutions to complex technical challenges.</li>
<li>Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders.</li>
<li>Demonstrated leadership capabilities, with experience leading cross-functional teams, projects, and initiatives to successful outcomes.</li>
<li>Proven ability to drive results and meet project timelines while maintaining high standards of quality and compliance.</li>
<li>Self-motivated and proactive attitude with a willingness to learn and adapt to new challenges, provide recommendations for continuous improvement.</li>
<li>Passion for improving healthcare through innovative technology solutions.</li>
</ul>

Physical Demands:
<ul>
<li>Sustained periods of time standing and sitting in a laboratory </li>
<li>Sitting at a desk utilizing a computer </li>
<li>Some lifting of&lt;25 pounds </li>
</ul>
Working Environment:
<ul>
<li>Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.</li>
</ul>
Travel:
<ul>
<li>Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.</li>
</ul>

Staff Mechanical Engineer

<h3>Job Description</h3>
Job Description
Job title:&nbsp;Engineer - Manufacturing Engineer I Duration:&nbsp;12 Months Location:&nbsp;Maple Grove MN 55311 Job Description:Job Purpose: Under supervisory direction, assist in the daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety). Key Responsibilities: 1. Performs troubleshooting on existing products/process problems as related to design, material, or processes. 2. Works cooperatively with Production and Quality engineers and technicians, as well as R&amp;D, Process Development, Regulatory, Equipment Engineering, and Supply Chain to ensure project success. 3. Trains operators/technicians on new processes and/or test procedures. 4. Identifies and implements improvements (e.g., yields, processes, and productivity). 5. Undertakes and successfully completes simple or basic product support tasks to include any of the following: verifying specifications, maintaining product/process documentation, testing processes, equipment, raw materials and product, and validating equipment processes. 6. Designs and coordinates rudimentary engineering tests and experiments. 7. Summarizes, analyzes, and provides recommendations from test results. 9. Prepares standard reports/documentation to document process changes and communicate results to the technical community. 10. Assists in identification and implementation of production goals. Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Qualifications &amp; skills required: 1+ years with BS in Engineering (Electrical, Mechanical, Biomedical, etc.) Mechanical aptitude and ability to learn Preferred: Technical troubleshooting skills on equipment Adaptability and prioritization skills Data analysis and technical communication skills

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