Senior Mechanical Design Engineer

Required Skills
12+ years of experience in Mechanical Design and Product Development.
Strong expertise in SolidWorks and mechanical engineering fundamentals.
Proven experience in NPI/NPA projects.
Extensive experience in:
Product design and development
Design verification and validation
Engineering documentation
Test planning and execution
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 (FMEA, DFMEA, PFMEA).
Exposure to regulatory and compliance requirements for medical products.

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