Senior Mechanical Engineer - Med Device

Our client, an established global leader in the diagnostics and medical device sector, is currently seeking a Senior Mechanical Engineer to join their growing R&D team. This role offers the opportunity to work on advanced diagnostic instruments and devices that directly impact patient care and clinical outcomes.

• Lead the design and development of mechanical components and subsystems for complex medical devices, from concept through to production.

• Collaborate with cross-functional teams, including electrical, software, and systems engineering, to ensure seamless integration of mechanical designs.

• Apply engineering principles to analyze problems, generate solutions, and validate design performance through simulations and testing.

• Develop and maintain documentation in compliance with industry standards and regulatory requirements (e.g., ISO 13485, FDA).

• Support verification and validation activities, including root cause analysis and design optimization.

• Participate in design reviews, risk assessments, and failure mode analysis (FMEA).

• Bachelors or Masters degree in Mechanical Engineering or related field.

• 510+ years of experience in mechanical design, preferably within the medical device industry.

• Strong proficiency in 3D CAD software (e.g., SolidWorks or Creo).

• Experience with precision mechanisms, fluidics, injection molding, and sheet metal design.

• Knowledge of design for manufacturability (DFM) and design for assembly (DFA) principles.

• Familiarity with regulatory and quality systems related to medical devices (e.g., FDA, ISO).