Description

Lead mechanical design for electromechanical medical device programs, owning architecture, interfaces, and release from concept to production.

This role is on-site.

Responsibilities

• Define mechanical architecture for enclosures, mechanisms, thermal paths, and cable routing while ensuring EMI/EMC compliance.
• Develop and review 3D CAD models, detailed drawings with GD&T, and BOMs for full lifecycle development.
• Execute design verification strategies (EVT, DVT, V&V) and resolve failures from testing or manufacturing feedback.
• Apply DFM/DFA principles and support design transfer, including pilot builds and supplier collaboration.
• Lead risk management (dFMEA, pFMEA) and maintain Design History File documentation in compliance with ISO 13485 and FDA 21 CFR 820.

Required Skills

• 8–12 years of mechanical design experience, with significant medical device NPD in regulated environments.
• Strong proficiency in SolidWorks or Creo for 3D modeling and drafting.
• In-depth knowledge of materials, manufacturing processes, and electromechanical integration.
• Expertise in GD&T (ASME Y14.5), tolerance stack-ups (hand calculations and FEA), and DFM/DFA.
• Experience with PLM and QMS tools such as Windchill or Agile.
• Understanding of thermal considerations, reliability, and ISO 14971 risk management.
• Bachelor’s or Master’s degree in Mechanical Engineering.

Preferred Skills

• Experience mentoring junior and mid-level engineers.
• Proven track record of leading technical discussions and design reviews.

Key Skills

Education

Bachelor's degree