Currently recruiting for a seasoned professional to take on a Senior Verification and Validation Engineer role within a highly regulated medical device environment. This position is focused on the hands-on execution and design of manual test cases and procedures, supporting the release of innovative diagnostic systems. You’ll be embedded in a collaborative, multidisciplinary team, helping ensure product reliability, safety, and compliance with stringent healthcare standards.
This is a 100% onsite role based at a facility in Rochester, with occasional travel (up to 20%) both domestically and internationally, including overnight stays.
Key Responsibilities:
- Develop and execute manual verification and validation test protocols for embedded medical systems in a BL2 laboratory setting
- Collaborate closely with development teams to assess testability of requirements and define effective test strategies
- Analyze, document, and manage defects throughout the product lifecycle
- Take part in peer reviews, technical meetings, and cross-functional planning sessions
- Engage in routine remote meetings with international partners (including off-hours, as needed)
- Support regulatory documentation and compliance initiatives throughout the product development process
- Provide input to improve V&V methodologies and testing workflows
- Contribute to ensuring projects stay on schedule and meet product launch milestones
- Carry out other relevant tasks as assigned
Qualifications & Skills:
- Bachelor’s or Master’s degree in Engineering, Computer Science, Chemistry, Biology, Biochemistry, or a related field
- 10+ years of experience in engineering roles, ideally within the medical device industry
- Strong understanding of verification and validation processes for instrumented systems
- Familiarity with medical device regulatory standards such as IEC 62304, ISO 13485, ISO 14971, and FDA QSR
- Experienced in defect tracking systems, configuration management tools, and application lifecycle management (Agile methodology preferred)
- Able to design experiments, interpret results, and document findings accurately
- Strong organizational, communication, and teamwork skills
- Adept at writing test plans, test cases, and producing clear test documentation
- Proficient in standard productivity software (e.g., Word, Excel, statistical tools)
- Demonstrates initiative, accountability, and a drive to deliver high-quality results
- Knowledge of risk management, design control, and medical device quality systems is a strong asset
- Must be authorized to work in the U.S. without visa sponsorship
