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
Benötigen Sie weitere Hilfe? Greifen Sie zu an einen unserer Mitarbeiter.
Wir sind ein vertrauenswürdiger Partner für jeden Schritt von der Entdeckung bis zur Entwicklung. Egal, wo Sie sich auf Ihrer Reise befinden, wir sind hier, um Ihnen zu helfen, etwas zu bewirken. Wir sind ein vertrauenswürdiger Partner für jeden Schritt von der Entdeckung bis zur Entwicklung. Egal, wo Sie sich auf Ihrer Reise befinden, wir sind hier, um Ihnen zu helfen, etwas zu bewirken. an einen unserer Mitarbeiter.