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<h3>Job Description</h3>
Job Description
About Us:&nbsp; We are a dynamic and innovative medical device startup developing a point-of-care portable blood coagulation testing device. Our full-time team currently comprises a CEO/Biomedical Engineer, and an Electrical Engineer.&nbsp;
Job Summary:&nbsp; We are seeking a talented and experienced Senior Software Engineer to join our team and lead the development and optimization of software workflows for our innovative acoustic tweezing technology-based medical devices. The ideal candidate will have a Master's degree in Computer Science, Software Engineering, or a related field, with a minimum of 5 years of experience. This role requires strong coding skills in Python and C/C++, proficiency in developing intuitive and visually engaging graphical user interfaces, and expertise in SQL for effective data management and database design. Experience with version control systems, particularly Git, is essential, along with the ability to understand and generate code from workflow diagrams. As the first and only software engineer on the team, you will play a pivotal role in shaping the software development efforts for our groundbreaking technology. This role is critical to the success of our product and involves working on multiple federal grants and projects.&nbsp;
Startup Environment:&nbsp; We operate in a fast-paced startup environment where innovation, adaptability, and a proactive mindset are key to success. We are looking for individuals who are passionate about working in a startup setting and thrive in dynamic and challenging situations. We value individuals who are not just seeking a job but are driven by a genuine passion for creating impactful solutions and driving change in the medical device industry. Our team members are expected to work well under pressure, juggle multiple projects, and be flexible in their roles as the needs of the company evolve. If you are excited about the opportunity to make a meaningful impact and are ready to roll up your sleeves and tackle challenges head-on, we encourage you to apply.&nbsp;
Key Responsibilities:&nbsp;
<ol>
<li>
Optimize and Enhance Existing Software:&nbsp;
</li>
</ol>
<ul>
<li>
Improve the efficiency of our existing software written in Python.&nbsp;
</li>
</ul>
<ul>
<li>
Increase processing speed for short-term operation on laptops.&nbsp;
</li>
</ul>
<ul>
<li>
Convert and optimize the software for embedded computing devices inside the medical device long-term.&nbsp;
</li>
</ul>
<ol>
<li>
Software Packaging and Security:&nbsp;
</li>
</ol>
<ul>
<li>
Secure the code to prevent reverse engineering.&nbsp;
</li>
</ul>
<ul>
<li>
Package the software into executable files for easy installation and deployment.&nbsp;
</li>
</ul>
<ol>
<li>
Connectivity and Data Management:&nbsp;
</li>
</ol>
<ul>
<li>
Ensure the software can connect to the internet.&nbsp;
</li>
</ul>
<ul>
<li>
Implement connectivity to an online database for long-term data management.&nbsp;
</li>
</ul>
<ul>
<li>
Incorporate Data Science, Machine Learning, and AI for handling large amounts of health data.&nbsp;
</li>
</ul>
<ol>
<li>
Health Data Security:&nbsp;
</li>
</ol>
<ul>
<li>
Ensure the highest level of security for software and health data management.&nbsp;
</li>
</ul>
<ol>
<li>
New Technique Development:&nbsp;
</li>
</ol>
<ul>
<li>
Convert and develop existing crude MATLAB codes and technology algorithms into efficient software for commercial use.&nbsp;
</li>
</ul>
<ul>
<li>
Create executable files with efficient large data handling capabilities.&nbsp;
</li>
</ul>
<ul>
<li>
Develop complex data processing software and manage large data analysis.&nbsp;
</li>
</ul>
<ul>
<li>
Develop a user-friendly interface for healthcare professionals.&nbsp;
</li>
</ul>
<ul>
<li>
Implement a remote kill switch for the software.&nbsp;
</li>
</ul>
<ul>
<li>
Apply all relevant requirements from existing software.&nbsp;
</li>
</ul>
<ol>
<li>
Parallel Processing and Language Conversion:&nbsp;
</li>
</ol>
<ul>
<li>
Implement efficient parallel processing techniques.&nbsp;
</li>
</ul>
<ul>
<li>
Convert existing Python code to C/C++ or another suitable low-level efficient language to run software optimally on embedded hardware.&nbsp;
</li>
</ul>
<ol>
<li>
Other Responsibilities:&nbsp;
</li>
</ol>
<ul>
<li>
Develop high-quality, efficient, and maintainable code.&nbsp;
</li>
</ul>
<ul>
<li>
Design intuitive and visually engaging user interfaces.&nbsp;
</li>
</ul>
<ul>
<li>
Proactively take on new responsibilities and suggest innovative ideas for product and company growth.&nbsp;
</li>
</ul>
<ul>
<li>
Participate in grant writing and fundraising activities.&nbsp;
</li>
</ul>
<ul>
<li>
Engage in FDA-related activities and adhere to quality protocols.&nbsp;
</li>
</ul>
<ul>
<li>
Perform other relevant software-related tasks as needed for the company.&nbsp;
</li>
</ul>
Minimum Qualifications:&nbsp;
<ul>
<li>
Master’s degree in Computer Science, Software Engineering, or a related field.&nbsp;
</li>
</ul>
<ul>
<li>
Minimum of 5 years of experience in software development.&nbsp;
</li>
</ul>
<ul>
<li>
Strong coding skills in Python, C, and C++ (JavaScript is a plus).&nbsp;
</li>
</ul>
<ul>
<li>
Proficiency in developing intuitive and visually engaging graphical user interfaces.&nbsp;
</li>
</ul>
<ul>
<li>
Proficiency in SQL for effective data management and database design.&nbsp;
</li>
</ul>
<ul>
<li>
Experience with version control systems, particularly Git.&nbsp;
</li>
</ul>
<ul>
<li>
Ability to understand and generate code from workflow diagrams.&nbsp;
</li>
</ul>
<ul>
<li>
Knowledge of integrating multiple devices and establishing centralized control.&nbsp;
</li>
</ul>
<ul>
<li>
Familiarity with IDEs, preferably PyCharm.&nbsp;
</li>
</ul>
<ul>
<li>
Excellent problem-solving skills and ability to work independently.&nbsp;
</li>
</ul>
<ul>
<li>
Strong written and verbal communication skills.&nbsp;
</li>
</ul>
Preferred Qualifications:&nbsp;
<ul>
<li>
Experience working in the medical device industry.&nbsp;
</li>
</ul>
<ul>
<li>
Familiarity with Agile development methodologies.&nbsp;
</li>
</ul>
<ul>
<li>
Knowledge of machine learning techniques and algorithms.&nbsp;
</li>
</ul>
<ul>
<li>
Experience with Docker and containerization technologies.&nbsp;
</li>
</ul>
<ul>
<li>
Familiarity with cloud platforms such as AWS or Azure.&nbsp;
</li>
</ul>
<ul>
<li>
Prior experience working in startups.&nbsp;
</li>
</ul>
<ul>
<li>
Experience with embedded systems and medical device software development.&nbsp;
</li>
</ul>
<ul>
<li>
Strong knowledge of data security, especially related to health data.&nbsp;
</li>
</ul>
<ul>
<li>
Knowledge of parallel processing and algorithm optimization.&nbsp;
</li>
</ul>
<ul>
<li>
Innovative mindset with a track record of proactive contributions.&nbsp;
</li>
</ul>
<ul>
<li>
Experience in grant writing and regulatory compliance (FDA).&nbsp;
</li>
</ul>
What We Offer:&nbsp;
<ul>
<li>
Competitive salary&nbsp;
</li>
</ul>
<ul>
<li>
Health, dental, and vision insurance coverage&nbsp;
</li>
</ul>
<ul>
<li>
Generous paid time off&nbsp;
</li>
</ul>
<ul>
<li>
Professional development opportunities&nbsp;
</li>
</ul>
<ul>
<li>
Potential to receive stock options&nbsp;
</li>
</ul>
<ul>
<li>
Opportunities for growth within the company&nbsp;
</li>
</ul>
<ul>
<li>
Flexible work arrangements, including remote work options&nbsp;
</li>
</ul>
<ul>
<li>
Dynamic and innovative startup environment&nbsp;
</li>
</ul>
<ul>
<li>
Opportunity to make a meaningful impact in the medical device industry&nbsp;
</li>
</ul>
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WVXkHF8KFK

Senior Software Engineer for Medical Device Startup

<h3>Job Description</h3>
Job Description
Join the Innovation Engine at Advanced Instruments, a part of Nova Biomedical
 
 At Advanced Instruments, now proudly part of Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. As a global leader in analytical technologies for the biopharmaceutical and clinical markets, our solutions are trusted in over 100 countries to accelerate drug development and enhance patient care.
Together, we are united by a bold vision: to improve the health of every patient through innovation and excellence. Our mission is to deliver smart, science-driven solutions that optimize processes, increase efficiency, and ensure confidence in results—ultimately leading to better outcomes for patients and providers alike.
Our integration brings together over 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. From FDA-registered, ISO-certified manufacturing to 125+ FDA approvals and industry-trusted diagnostics, we set the standard for quality and reliability. Advanced Instruments is also the global leader in osmolality testing, with a legacy of innovation that continues to shape the future of life sciences.
With headquarters in Norwood and Waltham, Massachusetts, and a growing global presence of 1,965 employees, we’re building an empowered, collaborative culture grounded in our shared values: Customer Centricity, Ingenuity, Ownership &amp; Accountability, Collaboration, and Integrity. We’re honoring our founder led legacies—and shaping a future defined by impact.
Explore what’s next with us at <a href="http://www.novabiomedical.com" target="_blank">http://www.novabiomedical.com</a> or <a href="https://www.aicompanies.com" target="_blank">https://www.aicompanies.com</a>
 
 
About the role
 
 As a Senior Software Engineer (UI), you’ll be at the forefront of crafting intuitive, high-performance interfaces for software platforms that power Osmometry instrumentation—spanning both new systems and legacy applications. You’ll collaborate closely with a multidisciplinary team of Software, Firmware, and Hardware Engineers to bring elegant, user-centric solutions to life.
In our fast-moving commercial environment, success hinges on decisive action and thoughtful execution. You’ll drive usability and innovation across our product suite by making informed technical decisions, engaging stakeholders for critical input, and proactively surfacing challenges. This role is ideal for someone who thrives on turning complexity into clarity and is passionate about delivering impactful user experiences.
 
What we are looking for in you: 
<ul>
<li>Commercial experience in C#/.NET Programming Experience in Visual Studio</li>
<li>Solid understanding of Object-Oriented Design and Principles</li>
<li>Commercial experience on an Agile team, with comfort in sprint planning, stand-ups, sprint review, retrospectives, and backlog refinement</li>
<li>Be accountable for development and delivery of assigned software features and/or applications within a cross functional team, from design through validation, within an Agile Software development team</li>
<li>Refactor existing code to proactively avoid roadblocks and avoid technical debt</li>
<li>Take part in group breakdown of new software features into actionable work items, and work with the team to estimate the time and complexity involved in them</li>
<li>Implement software design language and branding goals from Marketing</li>
<li>Support Software QA team automated UI test suite development</li>
<li>Able to work onsite in Norwood, MA</li>
<li>Degree in Computer Science, Engineering, or Science field </li>
</ul>
 
 
EEO Statement:
Advanced Instruments takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Advanced Instruments will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Privacy policy
<a href="https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW" target="_blank">https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW</a>

Senior Software Engineer (UI)

<h3>Job Description</h3>
Job Description
About Nudge
At Nudge, our mission is to develop the best technology for interfacing with the brain to improve people's lives. We're starting with an approach that we believe can help the most people the fastest, and also allow us to learn as much about the brain as possible: developing a non-invasive, ultrasound-based device that can stimulate and image the brain at high resolution and depth. This is a vertically integrated effort building cutting-edge hardware, software, and research capabilities to create products that can benefit millions — and eventually billions — of people.
We’ve brought together a team of the best, who believe hard things are worth doing. To succeed, we need to assemble world-class teams across everything we do. We hire people who are exceptional at their craft, do the real work, and execute relentlessly — people who expect the highest levels of both rigor and integrity from each other.
About the role
As an ultrasound engineer at Nudge, you will:
<ul>
<li>
Improve acoustic models of transducer arrays and subject-specific acoustic properties with feedback from benchtop and clinical testing
</li>
<li>
Evaluate the devices for both safety and performance considerations
</li>
<li>
Inform the design of next-generation devices through modeling and prototype testing
</li>
<li>
Develop software and algorithms for signal processing, beamforming, holography, and imaging
</li>
</ul>
About you
We are looking for engineers of all levels, but regardless of your career level, you should have:
<ul>
<li>
Strong engineering / physics first principles
</li>
<li>
Experience with ultrasound metrology
</li>
<li>
Experience with acoustic modeling software
</li>
<li>
Strong understanding of biomedical applications of ultrasound
</li>
<li>
PhD in a relevant engineering discipline
</li>
<li>
Demonstrated history of exceptional technical contribution
</li>
</ul>

Ultrasound Engineer

<h3>Job Description</h3>
Job Description
Job Summary:&nbsp; &nbsp;We’re looking for a motivated Biomedical Technician to join our team. In this role, you’ll help support the safe and effective use of medical equipment by performing basic repairs, routine maintenance, and safety checks. You’ll work closely with clinical teams to ensure equipment is functioning properly and assist with documentation and troubleshooting.
Responsibilities:
<ul>
<li>Perform scheduled maintenance and safety testing on medical equipment</li>
<li>Assist with basic repairs and hardware replacements</li>
<li>Support clinical staff by responding to equipment issues and troubleshooting problems</li>
<li>Maintain accurate records of service activities and equipment status</li>
<li>Help with equipment setup and relocation as needed</li>
<li>Follow established procedures and safety standards</li>
<li>Collaborate with other technicians and departments to ensure smooth operations</li>
</ul>
Required Qualifications:
<ul>
<li>Associate’s degree in Biomedical Equipment Technology, Electronics Technology, or applicable military training</li>
<li>Willingness to travel locally if needed (valid driver’s license and insurance may be required)</li>
</ul>
Preferred Qualifications:
<ul>
<li>Biomedical Technician certification (or willingness to pursue)</li>
<li>Experience working with medical equipment in a healthcare setting</li>
</ul>
Why Join Us:&nbsp; &nbsp;
<ul>
<li>Medical, dental, and vision coverage</li>
<li>Retirement savings with employer match</li>
<li>Paid time off and parental leave</li>
<li>Tuition reimbursement</li>
<li>Employee assistance programs and more</li>
</ul>
Exact compensation may vary based on several factors, including skills, experience, and education.
Benefit packages for this role may include healthcare insurance offerings and paid leave as provided by applicable law.

BMET III or Clinical Engineer 3

<h3>Job Description</h3>
Job DescriptionDescription:
Job purpose
 
The Process Engineer I is responsible for evaluating and improving manufacturing processes to reduce cost, improve yields, and reduce variation. This position performs new process design and implementation, process validations and process qualifications. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to manufacturing from R&amp;D. Process Engineer I makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above.
 
Duties and responsibilities
 
<ul>
<li>Plan and execute process optimization, equipment qualification, and process validation or process qualification projects.</li>
<li>Use LEAN Manufacturing principles to analyze processes and make recommendations for improvements.</li>
<li>Lead and perform equipment qualifications, process validations or process qualifications, including writing of protocols and reports.</li>
<li>Lead efforts to solve problems using formal problem resolution techniques and root cause analysis.</li>
<li>Create, communicate, and follow project plans with detailed tasks and timelines necessary for project completion. Communicate to management of performance against plan.</li>
<li>Identify and resolve insufficiencies in routine manufacturing and provide constant support to manufacturing team.</li>
<li>Develop standard operating procedures (SOPs) for newly designed or optimized processes, while ensuring compliance with safety and quality standards. </li>
<li>Assess processes, take measurements, and interpret data.</li>
<li>Develop and monitor process and equipment metrics to use for optimization analysis.</li>
<li>Comply with FDA and AATB tissue banking standards.</li>
<li>Other duties as assigned.</li>
</ul>
 
Requirements:
Qualifications
 
Qualifications include:
<ul>
<li>BS in Biomedical, Mechanical or Industrial Engineering or other applicable engineering discipline. Advanced degree (Master’s) a plus.</li>
<li>1-3 years of experience in Tissue Banking, Device, Biologics, or Pharmaceutical industry in a relevant engineering role preferred.</li>
<li>Strong analytical, planning, project management, critical thinking, troubleshooting, clear communication, and problem-solving skills.</li>
<li>Ability to effectively communicate with multidisciplinary teams. </li>
<li>Excellent technical skills and writing.</li>
<li>Strong knowledge of LEAN manufacturing principles preferred.</li>
<li>Working knowledge of 21 CFR 1271 regulations and AATB guidelines preferred.</li>
<li>Proficient in project planning software. Microsoft Project preferred.</li>
<li>CTBS certified (or certified within two years of employment).</li>
<li>Strong work ethics.</li>
</ul>
 
Working conditions
 
Job requires working in office. Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing. 
 
Physical requirements
 
The job may entail the occasional requirement to stand for extended periods of time and lifting heavy objects of up to 30 lbs. and do repetitive tasks with few breaks while executing engineering plans.
 
Direct reports
No direct reports

Process Engineer I

<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
Description
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines &amp; Values:
<ul>
<li>We empower and support our colleagues</li>
<li>We commit to client success at every turn</li>
<li>We have the courage to do the right thing</li>
<li>We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.</li>
<li>We constantly acquire new skills and learn from our experiences to enhance our collective expertise</li>
</ul>
CQV Engineer Responsibilities (Typical):
<ul>
<li>Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis</li>
<li>Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release</li>
<li>Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader</li>
<li>Running test scripts and documenting results</li>
<li>Adherence with project schedule for all assigned activities</li>
<li>Maintaining clear, detailed records qualification and validation</li>
<li>Documenting impact and risk assessments as part of a team</li>
<li>Completing user interface testing, software verification, and complete alarm testing on automated systems</li>
<li>Developing, reviewing, and executing testing documentation</li>
<li>Making recommendations for design or process modification based on test results when executing test scripts</li>
<li>Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment</li>
<li>General understanding of capital equipment implementation and process knowledge</li>
<li>Understanding validation documents, URS, IQ, OQ, PQ</li>
<li>Verifying system drawings including ability to review and as-built P&amp;IDs (piping and instrumentation drawings) and I&amp;C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer</li>
</ul>

Requirements:
<ul>
<li>Must be able to meet onsite work requirements in Holly Springs, NC</li>
<li>Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)</li>
<li>2-4 years of relevant industry experience</li>
<li>Proficiency using PC and Microsoft Office tools</li>
<li>Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms</li>
<li>Ability to work as part of a team</li>
<li>Strong problem-solving and critical thinking skills</li>
<li>Excellent organizational and time management skills</li>
<li>Strong attention to detail</li>
<li>GMP and Good Documentation Practice training (may be completed at onboarding)</li>
<li>Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)</li>
<li>Basic skills with EXCEL and PowerPoint</li>
<li>Strong interpersonal skills and clear communication capabilities</li>
</ul>
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
National (US) Range$65,000—$104,439 USD
Benefits
Why Choose Verista?
<ul>
<li>High growth potential and fast-paced organization with a people-focused culture</li>
<li>Competitive pay plus performance-based incentive programs</li>
<li>Company-paid Life, Short-Term, and Long-Term Disability Insurance.</li>
<li>Medical, Dental &amp; Vision insurances</li>
<li>FSA, DCARE, Commuter Benefits</li>
<li>Supplemental Life, Hospital, Critical Illness and Legal Insurance</li>
<li>Health Savings Account</li>
<li>401(k) Retirement Plan (Employer Matching benefit)</li>
<li>Paid Time Off (Rollover Option) and Holidays</li>
<li>As Needed Sick Time</li>
<li>Tuition Reimbursement</li>
<li>Team Social Activities (We have fun!)</li>
<li>Employee Recognition</li>
<li>Employee Referral Program</li>
<li>Paid Parental Leave and Bereavement</li>
</ul>
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5832- CQV Engineer / Validation Engineer 2

<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>
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.

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