Senior Mechanical Design Engineer

My Client is seeking a highly skilled and experienced Senior Mechanical Design Engineer to lead the mechanical development of complex medical and electronic devices from concept through production. This role requires a deep understanding of mechanical engineering principles, materials, manufacturing processes, and regulatory requirements specific to the medical device industry.

Key Responsibilities

• Lead mechanical design efforts for new product development and existing product improvements.
• Develop 3D CAD models, detailed drawings, and specifications using tools such as SolidWorks or Creo.
• Collaborate with cross-functional teams including electrical, software, quality, and regulatory to ensure cohesive product development.
• Perform tolerance analysis, FEA, and thermal analysis to validate designs.
• Select appropriate materials and manufacturing processes (e.g., injection molding, CNC machining, sheet metal fabrication).
• Create and maintain design documentation in accordance with ISO 13485 and FDA QSR requirements.
• Support design verification and validation activities, including test planning and execution.
• Interface with suppliers and contract manufacturers to ensure design intent is met during production.
• Mentor junior engineers and provide technical leadership within the team.

Qualifications

Required:

• Bachelor's or Master's degree in Mechanical Engineering or related field.
• 5+ years of experience in mechanical design, preferably in the medical device or electronics industry.
• Proficiency in 3D CAD software (SolidWorks, Creo, or equivalent).
• Strong knowledge of DFM/DFA principles and GD&T.
• Experience with regulatory standards such as ISO 13485, IEC 60601, and FDA 21 CFR Part 820.
• Excellent problem-solving, communication, and project management skills.