Independently research, design, develop, and verify components and subsystems for medical devices
Lead advanced prototyping and testing activities; analyze and resolve complex design issues.
Apply deep knowledge of customer needs, clinical procedures, and market trends to inform design inputs; support Voice of Customer sessions.
Ensure adherence to industry standards and regulations; lead creation and refinement of engineering documentation, including Design History Files.
Follow and mentor others on design controls, risk management, and R&D procedures per the Quality Management System.
Partner with Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to drive project success.
Identify and implement enhancements to procedures, policies, processes, and technology.
Deliver high-quality results with energy and accountability; support complex, multifunctional projects through design, development, and launch.

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or a related discipline
6+ years of relevant work experience
Experience working in a New Product Development environment
Experience working in the medical device industry.
Strong technical expertise in designing and optimizing mechanical and electro-mechanical assemblies
Proficiency in creating detailed engineering drawings and models, including GD&T, and using CAE tools to support robust design development.
Demonstrated ability to analyze designs using advanced methods such as DFMECA, Fault Tree Analysis, FEA, and tolerance stack-ups to ensure performance and reliability.
Ability to clearly communicate moderately complex technical plans and concepts to team members, with experience in capital equipment or console-based systems preferred.

Senior Staff Mechanical Design Engineer

Key skills