Medical Device Verification and Validation Engineer

1 week ago

Woburn, Massachusetts, United States Incendia Partners Full time
Job DescriptionJob DescriptionMedical Device Verification and Validation Engineer
Greater Boston
(relocation and sponsorship is not available)

Summary
As a member of the Product Development team, the Medical Device Verification & Validation Engineer will be responsible for designing, executing, and analyzing tests on electro-mechanical based medical devices to ensure their quality, safety, and compliance with regulatory standards.

The ideal candidate should have a strong background in medical device testing, knowledge of electro-mechanical designs, relevant regulations and standards. They will have excellent analytical and problem-solving abilities. The Medical Device Verification & Validation Engineer will work closely with the R&D and Quality teams to ensure that the companys products and systems meet all design requirements, and that activities are conducted in compliance with company policies as well as appropriate regulations for medical devices.The position may be required to perform all, or a combination of the following essential responsibilities as determined by necessity.

This is an on site role located in the Greater Boston area.

Essential Duties and Responsibilities
  • Develop test plans and strategies based on regulatory requirements, industry standards, and product specifications.
  • Design and execute test protocols to evaluate the performance, functionality, and safety of medical devices.
  • Utilize specialized equipment and simulate real-world conditions to conduct tests.
  • Analyze test data, interpret results, and collaborate with cross-functional teams to troubleshoot issues and optimize device performance.
  • Generate comprehensive test reports documenting test procedures, results, and any non-compliance issues.
  • Ensure compliance with relevant regulations, such as FDA guidelines or international standards like ISO 13485.
  • Collaborate with product designers, quality assurance personnel, and regulatory affairs specialists to ensure effective testing processes.
  • Participate in design reviews, providing input on testability and manufacturability of medical devices.
  • Contribute to risk assessment activities and ensure that devices meet design requirements and user needs through verification and validation tests.
  • Identify opportunities to streamline testing procedures, enhance efficiency, and optimize resource utilization.
  • Participates in the design and development of automated tools, test fixtures, and unit tests.
  • Stay updated on emerging technologies, industry trends, and regulatory changes relevant to medical device testing.
  • Performs other duties as required.

Education and/or Experience
  • Bachelors degree in Biomedical Engineering, Electrical Engineering, or a related field.
  • 5 years of experience in medical device testing or a similar role.
  • Strong knowledge of medical device regulations and standards (ISO 13485, ISO 14971, IEC 62304, 21 CFR part Design Controls, FDA SW Guidelines).
  • Proficient in designing and executing test plans, protocols, and procedures.
  • Experience with specialized testing equipment and tools (Git, SVN, WinSCP, TeraTerm, VMWare, VirtualBox).
  • Experience working with test case/work management tools such as Helix and Jira.
  • Experience working with different test methodologies (white-box testing, black-box testing, boundary value analysis, equivalence partitioning, use case testing).
  • Experience working with embedded software, Linux and Android OS platforms.
  • Experience programming and reviewing code (C++, XML, Java, Python).
  • Ability to analyze and interpret complex test data.
  • Strong written and verbal communication skills.
  • Detail-oriented with a high level of accuracy.
  • Ability to work effectively in cross-functional teams.
  • Familiarity with risk assessment methodologies and verification/validation processes.
  • Our Client offers a friendly and collaborative work environment where each person is recognized for their contributions and successes. The company believes insupporting a healthy work/life balance and backs that up with a comprehensive medical/dental and vision care health plan, a 401K with company matching, generous PTO, holiday and sick time among other benefits.

Apply today - this is an immediate need.
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Company DescriptionA Winner of Inavero's Diamond Award Best of Staffing Client and Talent Awards for providing superior service to our clients and job seekers and an Inc. 500 honoree three consecutive years from , Incendia provides recruiting and staffing services to companies that have resource or hiring needs.

Incendia Partners, the most progressive provider of recruiting and staffing services is fueled by a single purpose: finding the solution to your staffing needs.

With over 20 years of recruiting experience, we use our talent to find the talent you need. Our simple, straightforward process cuts through the clutter, arming you with the right facts for maximum efficiency. We help you fill more positions faster, all while never sacrificing the personal touch that sets us apart from the rest. Whether you're a business looking for full-time, contract, contract-to-hire or just need hourly or project based recruiting services in Software & IT, Accounting & Finance, Human Resources, or just about any position you're hiring for, or you are a professional looking for your next great career opportunity, Incendia will fire on all cylinders until you meet your match.Company DescriptionA Winner of Inavero's Diamond Award Best of Staffing Client and Talent Awards for providing superior service to our clients and job seekers and an Inc. 500 honoree three consecutive years from , Incendia provides recruiting and staffing services to companies that have resource or hiring needs. \r
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Incendia Partners, the most progressive provider of recruiting and staffing services is fueled by a single purpose: finding the solution to your staffing needs. \r
\r
With over 20 years of recruiting experience, we use our talent to find the talent you need. Our simple, straightforward process cuts through the clutter, arming you with the right facts for maximum efficiency. We help you fill more positions faster, all while never sacrificing the personal touch that sets us apart from the rest. Whether you're a business looking for full-time, contract, contract-to-hire or just need hourly or project based recruiting services in Software & IT, Accounting & Finance, Human Resources, or just about any position you're hiring for, or you are a professional looking for your next great career opportunity, Incendia will fire on all cylinders until you meet your match.

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