Senior Mechanical Design Engineer

Role Overview

Required Skills

• At least 12 years of experience in mechanical design and product development.
• Strong expertise in SolidWorks and mechanical engineering fundamentals.
• Proven experience in NPI/NPA projects.
• Experience with product design, design verification and validation, engineering documentation, test planning, and test execution.
• Experience with problem-solving and root cause analysis.
• Strong knowledge of GD&T and manufacturing processes.
• Experience working with suppliers, contract manufacturers, and cross-functional teams.
• Ability to independently drive projects and resolve technical challenges.

Preferred Qualifications

• Experience in the medical device domain.
• Knowledge of ISO 13485, FDA design controls, and medical product development processes.
• Experience with risk management methodologies including FMEA, DFMEA, and PFMEA.
• Exposure to regulatory and compliance requirements for medical products.

Responsibilities

• Drive mechanical design and product development activities.
• Support NPI/NPA projects from design through product development.
• Plan and execute design verification and validation activities.
• Prepare and maintain engineering documentation.
• Develop test plans and execute product testing.
• Solve technical problems and perform root cause analysis.
• Apply GD&T and manufacturing process knowledge to product designs.
• Coordinate with suppliers, contract manufacturers, and cross-functional teams.
• Independently drive projects and resolve technical challenges.
• Apply risk management and medical product development practices when applicable.