Responsibilities:

• Collaborate with cross-functional teams (engineering, QA, regulatory, clinical) to support product development.
• Develop and conduct design verification and validation (V&V) tests.
• Support risk management activities, including FMEA, hazard analysis, and safety assessments.
• Ensure product compliance with medical device regulations.
• Participate in design reviews and provide technical input.
• Establish and validate production lines, including tooling and equipment.
• Implement quality control measures for consistent product output.
• Optimize supply chain management by collaborating with vendors for production planning.

Qualifications:

• Master’s degree in Mechanical Engineering or Biomedical Engineering.
• 10+ years of experience in medical device development, preferably with implantable devices.
• Strong knowledge of production engineering principles, including requirements management, risk analysis, and system integration.
• Experience in V&V testing and process validation, including technical documentation.
• Proficiency in system modeling tools and CAD software.

Reports to: VP of R&D