Senior Mechanical Engineer

About the Opportunity

Join a leading product development and engineering team focused on creating innovative medical technologies that improve lives. This role offers the opportunity to lead complex product development programs, work directly with clients, and collaborate with multidisciplinary engineering teams to bring new medical devices from concept through verification and commercialization.

What You'll Do

• Lead mechanical design and product development activities for medical device programs.
• Serve as a technical lead and mentor for engineering team members.
• Manage client interactions, design reviews, project timelines, and deliverables.
• Develop mechanical concepts, mechanisms, packaging solutions, and precision components.
• Design products using injection molding, machining, casting, laser cutting, welding, extrusion, and additive manufacturing methods.
• Perform prototyping, root cause analysis, tolerance stack analysis, FEA, and design optimization.
• Lead Design History File (DHF) development and FDA design control activities.
• Plan and execute verification testing, test method development, validation, and DOE activities.
• Collaborate with electrical, software, systems, human factors, and industrial design teams.
• Support project scoping, business development efforts, and risk management activities.

What You'll Bring

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years of medical device product development experience.
• Strong mechanical design background with SolidWorks expertise.
• Experience with FDA design controls and regulated product development.
• Working knowledge of ISO 13485, ISO 14971, and IEC 60601.
• Experience with DHF documentation, verification testing, and risk management.
• Proficiency in GD&T, tolerance analysis, and engineering documentation.
• Knowledge of sterilization methods, biocompatibility, sterile packaging, and validation testing.
• Experience within Neurology, Cardiovascular, Orthopedics, Women's Health, Diabetes, or related medical device markets preferred.