Senior Mechanical EngineerThe RoleAs Senior Mechanical Engineer, you'll help turn complex engineering challenges into reliable, manufacturable medical devices. You'll take ownership of mechanical and electromechanical development, from evaluating concepts and building prototypes through verification, validation, and commercialization.
This is a hands-on role for an experienced engineer who enjoys both the details and the bigger picture. You'll analyze designs, investigate failures, work directly with suppliers and manufacturing partners, and help ensure our products meet performance, quality, and regulatory requirements.
What You'll Do- Design and develop: Create mechanical and electromechanical components and systems, using feasibility studies, simulations, and prototypes to improve performance, functionality, and reliability.
- Design V&V Strategies: Oversee and approve design verification and validation strategies, protocols, and reports.
- Apply rigorous analysis: Perform engineering calculations, tolerance analysis, and finite element analysis covering stress, fatigue, and deflection.
- Use data to strengthen designs: Apply Minitab statistical tools, including capability/Cpk, ANOVA, and Gage R&R, to evaluate design robustness and measurement systems.
- Solve complex problems: Lead or support failure analysis, root cause investigations, and corrective and preventive actions.
- Own design risk management: Develop and maintain FMEAs, drive risk mitigation, and contribute to design reviews and risk assessments.
- Build for manufacturing: Partner with manufacturing teams and suppliers to develop and qualify injection molds and support consistent, scalable production.
- Work directly with suppliers: Participate in technical reviews, qualifications, and issue resolution with suppliers and external partners.
- Maintain clear documentation: Create and review engineering drawings, specifications, test plans, and supporting documentation for manufacturing, quality, and regulatory activities.
- Drive changes and improvements: Lead engineering change orders and impact assessments, support regulatory submissions, and improve engineering processes, tools, and documentation practices.
- Bring new thinking: Stay current with relevant technologies, industry developments, and regulatory changes, applying that knowledge to product improvements.
What You'll Bring- Bachelor's degree in Mechanical Engineering or a related field.
- At least seven years of relevant experience in the medical device industry.
- A demonstrated track record of taking medical device projects from concept through commercialization.
- Strong SolidWorks skills, including detailed designs, 3D models, and engineering drawings.
- Hands-on experience with engineering calculations, stress and tolerance analysis, simulations, and finite element analysis.
- Experience with medical device materials and manufacturing methods, including injection molding, machining, and additive manufacturing.
- Experience applying FMEA and other risk management methods to identify and mitigate design hazards and potential failures.
- Familiarity with medical device quality management systems, design controls, verification and validation, and documentation supporting regulatory submissions.
Preferred: Master's degree in Mechanical Engineering or a related field.
Work EnvironmentThis position is based onsite in San Diego and requires up to 20% travel. The role involves sitting or standing for extended periods and lifting or moving up to 35 pounds, with reasonable accommodation as applicable.
