Principal/Senior Mechanical Engineer

About the role

The Principal / Senior Mechanical Engineer will play a crucial role in the research and development team, focusing on the design, development, and optimization of complex medical devices, materials, and combination products from conception through launch.

Requirements

• BS in Mechanical engineering (Masters Preferred)
• 8+ years of dedicated mechanical design experience, with at least 5 years specifically in the medical device industry
• Expert-level proficiency in CAD/solid modeling (Solidworks or equivalent)
• Strong knowledge of materials & fabrication/manufacturing/injection molding technologies
• Experience with FEA, CFD or other engineering simulation tools
• Deep mastery of medical device design controls and regulations (e.g. ISO 13485, ISO 14971, ISO 60601)
• Ability to work independently, analyse data rigorously, and manage multiple priorities.
• Excellent written and verbal communication skills.

Responsibilities

• Lead the mechanical architecture and detailed design of complex, multi-component patient connected medical devices using CAD and simulation tools.
• Translate user needs into functional requirements and prototypes using advanced manufacturing techniques.
• Perform rigorous tolerance analysis (GD&T), structural/thermal FEA, and kinematic modeling to ensure absolute reliability in clinical environments.
• Architect and execute comprehensive Verification and Validation protocols within ISO 13485 and FDA 21 CFR Part 820 quality systems.
• Collaborate directly with manufacturing, quality, and supply chain teams to optimize designed for manufacturability (DFM), assembly (DFA), and cost at scale.
• Drive technical risk management (compliance with ISO 14971) through hazard analysis, fault tree analysis, FMEA, and rigorous root cause investigations.
• Provide technical guidance and mentorship to junior engineers and other design staff
• Manage multiple projects balancing technical priorities, timelines & budgets.
• Prepare technical documentation, reports and presentations for internal & external stakeholders.

Benefits

• Competitive salary and benefits package
• Opportunities for professional development and career growth.
• Collaborative and innovative work environment.