We are seeking a Systems Verification & Validation Engineer, R&D with a strong background in the medical device industry to join our engineering team. This role will be responsible for leading the verification and validation (V&V) efforts for electro-mechanical medical devices, ensuring compliance with regulatory standards, and collaborating across multiple functions to deliver high-quality products.
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3-5 years of experience in medical device verification and validation within a regulated industry.
Direct experience with Systems V&V for complex electro-mechanical medical devices.
Familiarity with industry standards, specifically ISO 13485
Proficiency in test methodology, automation, and data analysis.
Proven ability to write and execute system-level V&V protocols and review requirements.
· Experience with X-Ray or other radiological medical devices.
· Familiarity with developing test tools and methods for system verification.
· Knowledge of IEC 60601-1 and testing for hardware-firmware-software interface designs.
· Experience with requirement management tools such as JAMA or DOORS.
- Proficiency in Python or MATLAB for test automation and data analysis.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.