Principal Mechanical Engineer

Lead mechanical engineering strategy and execution for medical device products from concept through commercialization, ensuring designs are safe, manufacturable, reliable, and compliant with applicable regulatory requirements. This role owns key mechanical architecture decisions, mentors engineers, and partners cross-functionally to deliver robust, user-centered devices. 

Duties and responsibilities 

• Own mechanical system architecture for medical device and research products. 

• Translate user needs, industrial design intent, system requirements into engineering requirements and specifications and verifiable design outputs. 

• Execute mechanical design and documentation in alignment with medical device regulatory requirements, including risk management and supporting regulatory submissions. 

• Partner with cross-functional teams to deliver form, fit, comfort and aesthetics while meeting engineering, safety and compliance constraints.  

• Create, review and maintain CAD models, detailed drawings, tolerance stacks, and other mechanical specifications.  

• Drive design for manufacturing and design for assembly across prototypes and production; collaborate on or lead material and process selection. 

• Own mechanical aspects of supplier selection and development, including RFQs, technical reviews, tooling plans, DFM feedback incorporation, first article acceptance criteria. 

• Champion mechanical internal processes to establish industry best practices.  

• Oversee other engineers or external contractors as assigned. 

Qualifications 

• Bachelor’s degree in Mechanical Engineering, P.Eng. and Master’s degree preferred. 

• 10+ years of progressive mechanical engineering experience, including shipping at least one medical device.  

• Proven experience designing applied parts and/or wearable devices, with demonstrated attention to ergonomics, comfort, safety, durability and safety. 

• Must have prior experience with biocompatibility testing, ISO 10993.  

• Must have prior experience with mechanical aspects of medical device compliance testing. 

• Must have prior experience in electromechanical integration. 

• Prior experience of thermal management in electromechanical products (heat transfer, materials, enclosure design, etc.).