Key Responsibilities Design & Development: Create and test prototypes, disease models, and product designs aligned with regulatory standards.Clinical Collaboration: Work with KOLs and advisors to translate clinical needs into product solutions.Testing & Validation: Conduct in-vitro, in-vivo, and V&V testing; develop protocols and reports.Documentation & Compliance: Ensure quality system documentation and adherence to FDA regulations.Supplier Management: Source and maintain relationships with component suppliers.IP Development: Contribute to patent filings and invention disclosures.Cross-functional Teamwork: Represent R&D on core teams and support pilot manufacturing.Technical Leadership: Guide technology development teams and manage resources.  Qualifications Education: Bachelor’s (Master’s/PhD preferred) in Mechanical or Biomedical Engineering.   Experience:10+ years in medical device engineering.3+ years leading cross-functional teams.Expertise in balloon catheters, access/delivery systems, and disposable devices.   Skills:Strong material and design knowledge.Effective communicator and independent operator.Adaptable to fast-paced environments

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