Mechanical Engineer

We are seeking a Senior Mechanical Engineer with 4–5 years of experience in the Medical Device or Biotechnology industry. This role will lead mechanical design and development activities in a regulated environment and drive products from concept through commercialization.

The ideal candidate brings strong technical ownership, regulatory awareness, and hands‑on product development experience.

• Lead mechanical design of medical devices or biotech equipment from concept to launch.
• Develop 3D CAD models, detailed drawings, assemblies, and BOMs.
• Perform tolerance stack‑ups, GD&T application, and material selection.
• Conduct structural, thermal, and feasibility analyses as required.
• Drive Design for Manufacturing (DFM) and Design for Assembly (DFA) initiatives.
• Develop and maintain design control documentation (User Needs, Design Inputs/Outputs, V&V, Traceability Matrix).
• Ensure compliance with FDA regulations, ISO 13485, and GMP standards.
• Participate in design reviews and regulatory audit preparation.
• Develop and execute Design Verification & Validation (DV&V) protocols.
• Support pilot builds, process validation, and production transfer.
• Collaborate with contract manufacturers and vendors for tooling and prototyping.
• Lead root cause investigations and implement CAPA actions.
• Work closely with Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Mentor junior engineers as needed.
• Manage multiple projects and timelines effectively.

• Bachelor’s degree in Mechanical Engineering (Master’s preferred).
• 4–5 years of experience in Medical Device or Biotechnology product development.
• Hands‑on experience in regulated environments (FDA, ISO 13485).
• Proficiency in CAD software (Solid Works, Creo, or equivalent).
• Strong knowledge of:
• GD&T and tolerance analysis
• Plastics and metals design
• Injection molding and machining processes
• Risk management and FMEA

• Experience with Class II or Class III medical devices.
• Experience with sterile systems or cleanroom products.
• Familiarity with biotech instrumentation or diagnostic systems.