- 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
- 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.
- Bachelor's 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.
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds on occasion.
- Must be able to access and navigate each department at the organization's facility.
- This position requires minimal travel; average travel for this position is less than 5% with some variation based upon the demands of the business imperatives.
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Medical Device Test Engineer - Woburn, United States - Cytrellis Biosystems, Inc.
3 weeks ago
Description
We're HIRING Medical Device Test EngineerWe're looking for passionate and ambitious individuals to join the Cytrellis Team
What makes Cytrellis different:
• Unique product offering - ellacor by Cytrellis is the FIRST and ONLY FDA-cleared device for non-surgical, scarless skin removal.
• Untapped Market Potential: 5x account growth in the last 8 months
• Voted Best Non-Surgical Skin Removal Procedure
• Developed by aesthetic industry innovators Rox Anderson, MD and Jay Austen, MD from Mass General Hospital / Harvard Medical School
Don't miss your chance to join an amazing team that is shaping the future of aesthetics.
As a member of the Product Development team, the Medical Device Verification & Validation Test 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 V&V Test Engineer will work closely with the R&D and Quality teams to ensure that the company's 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 role is located at the Company's Headquarters located in Woburn, MA.
Essential Duties and Responsibilities
