Sr Mechanical Engineer

Senior Mechanical Engineer

Modular Medical is an emerging growth company with a big, stubborn idea: insulin pump therapy should be simpler, more affordable, and within reach of more people. Based in San Diego, we’re the team behind Pivot™, an FDA-cleared tubeless insulin patch pump designed for people who haven’t found their fit with traditional pumps. With about 50 employees, individual contributions make a visible difference here. Your ideas get heard, your work helps shape our products, and your impact reaches beyond the office into someone’s everyday life. If you like big challenges, small teams, and work with a clear purpose, we’d love to hear from you.

The Role As 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 Environment This 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.

Why Modular Medical? You’ll join a team where engineering decisions have a direct connection to the finished product - and to the people who use it. If you enjoy taking ownership, working across disciplines, and building practical solutions to meaningful problems, we’d like to hear from you.

Modular Medical, Inc. is an Equal Opportunity Employer. We consider qualified applicants without regard to race, color, religion, sex, pregnancy, gender identity, national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, employee organization membership, parental status, military service, or any other protected status. We prohibit retaliation.