Sr Mechanical Engineer
About The Position
Modular Medical is an emerging growth company based in San Diego, with about 50 employees. It develops Pivot™, an FDA-cleared tubeless insulin patch pump. The Senior Mechanical Engineer helps turn complex engineering challenges into reliable, manufacturable medical devices, taking ownership of mechanical and electromechanical development from concept evaluation and prototyping through verification, validation, and commercialization. The hands-on role includes design analysis, failure investigation, supplier and manufacturing-partner collaboration, and helping ensure products meet performance, quality, and regulatory requirements. The position is based onsite in San Diego and requires up to 20% travel.
Requirements
- Bachelor’s degree in Mechanical Engineering or a related field.
- At least seven years of relevant experience in the medical device industry.
- 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.
Nice To Haves
- Master’s degree in Mechanical Engineering or a related field.
Responsibilities
- Design and develop mechanical and electromechanical components and systems, using feasibility studies, simulations, and prototypes to improve performance, functionality, and reliability.
- Oversee and approve design verification and validation strategies, protocols, and reports.
- Perform engineering calculations, tolerance analysis, and finite element analysis covering stress, fatigue, and deflection.
- Apply Minitab statistical tools, including capability/Cpk, ANOVA, and Gage R&R, to evaluate design robustness and measurement systems.
- Lead or support failure analysis, root cause investigations, and corrective and preventive actions.
- Develop and maintain FMEAs, drive risk mitigation, and contribute to design reviews and risk assessments.
- Partner with manufacturing teams and suppliers to develop and qualify injection molds and support consistent, scalable production.
- Participate in technical reviews, qualifications, and issue resolution with suppliers and external partners.
- Create and review engineering drawings, specifications, test plans, and supporting documentation for manufacturing, quality, and regulatory activities.
- Lead engineering change orders and impact assessments, support regulatory submissions, and improve engineering processes, tools, and documentation practices.
- Stay current with relevant technologies, industry developments, and regulatory changes, applying that knowledge to product improvements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
