The Verification & Validation Engineer will be deeply involved in product testing, simulated use, and cross-functional collaboration with design, manufacturing, QA, product marketing, and product management teams. This is a hands-on, customer-facing role requiring direct engagement with surgeons and surgical teams to design and execute verification and validation activities.
Core Responsibilities
- Lead verification and validation (V&V) activities for new product development and sustaining engineering.
- Write test plans, protocols, and reports; execute testing in labs; oversee vendor testing.
- Plan and lead simulated use testing with surgeons and surgical teams (logistics, execution, reporting).
- Support regulatory and design control requirements.
- Collaborate cross-functionally with design engineers, manufacturing, QA/RA, and product management.
- Author verification and validation documentation to support regulatory submissions.
- Support risk analysis activities.
Requirements
- Strong verification and validation experience in medical devices (not software).
- Proven experience writing protocols and reports from scratch.
- Excellent technical writing and communication skills (clear, concise, explaining the “why”).
- Hands-on experience with simulated use testing; ability to lead protocols and coordinate with surgeons.
- Proactive and confident personality. Ability to take initiative, ask questions, and lead discussions.
Nice-to-Haves
- Orthopedics experience.
- Mechanical testing background (e.g., MTS, materials testing).
- Fixture design capability (machining/3D printing); team has support if candidate can’t build solo.
- Root cause/sustaining engineering experience.
- Awareness of materials testing or design experience (as long as candidate is committed to V&V focus).
Ideal Profile
- Engineering degree (Mechanical, Biomedical, or related).
- Minimum 3–5 years in medical device V&V (with flexibility if candidate has advanced degree + practical experience).
- Comfortable in a fast-paced environment.
- Confident communicator who can work directly with clinicians and cross-functional teams.
- Strong organizational skills and ability to balance writing/documentation with hands-on testing (approx. 50/50 or 60/40 split).
Additional Notes
- Relocation: No formal package
Need more help? Reach out<br></br> to one of our team.
We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.