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.

Education & Qualifications:

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. 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.

Disclaimer:

The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Benefits:

401(k) Dental insurance Employee assistance program Retirement plan

Work Location:

In person