Principal Mechanical Design Engineer

About the Role

Mini Med is looking for a Principal Mechanical Design Engineer for our San Diego office. The Principal Mechanical Design Engineer leads the development of new electromechanical medical device products and supports process development and design transfer to a contract manufacturer within a dynamic Hardware R&D environment. The role collaborates closely with Quality, Operations, Medical Affairs, Regulatory, and other cross-functional teams to advance projects in alignment with established objectives and timelines.

• Research, plan, design, verify, validate, and develop mechanical and electromechanical products and systems.
• Apply expertise in plastic part design, injection molding, design verification and validation, and design for manufacturing.
• Use design controls, risk analysis, and medical device development processes.
• Identify and recommend technology and process improvements to enhance safety, performance, efficiency, and cost.
• Support successful transfer of products from R&D into manufacturing.
• Proficiency with CAD tools such as Solid Works; experience with Medical Device Quality Management Systems and EDMS platforms such as Agile.
• Design and evaluate complex, compact electromechanical systems.
• Communicate technical information, apply sound judgment, account for results and interpret complex data while managing multiple priorities.
• Apply practical experience in process development, manufacturability, and product realization.

• Bachelor’s degree with at least 7 years of relevant experience, or Master’s degree with at least 5 years of relevant experience.

• Experience with in the medical device industry.
• Mastery of 3D CAD (Solid Works) and GD&T.
• Proven track record leading complex design projects and mentoring engineers.
• Excellent communication and collaboration skills.
• Broad knowledge of manufacturing processes (injection molding, machining, 3D printing, automated assembly).
• Deep knowledge of regulatory standards (FDA, ISO 13485) and risk management (FMEA, hazard analysis).
• Experience designing components for diabetes devices (insulin pumps, CGMs, infusion sets) or similar wearable/implantable medical devices.
• Advanced skills in tolerance analysis, predictive modeling and GD&T.
• Demonstrated success in launching products into high-volume manufacturing.
• Strong stakeholder management and negotiation skills.
• Experience with Finite Element Analysis (FEA).

The above statements describe the general nature and level of work performed by employees assigned to this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For office roles, the employee is regularly required to be independently mobile, interact with a computer and communicate with peers and co-workers.

Mini Med offers a competitive salary and flexible benefits package. Salary ranges for U.S. (exclusive of Puerto Rico) locations: $109,000–$185,000. For positions in California, Seattle, Washington DC, Boston, and New York City, the range is $121,000–$205,000. Compensation and benefits are subject to experience, education, certifications, skills and geographic location. Eligible employees may also benefit from a short-term incentive, 401(k) plan with company match, health, dental, vision, HSA, flexible spending account, life insurance, long-term disability, paid time off, holidays, employee stock purchase plan, employee assistance program, and non-qualified retirement plan supplement.

Mini Med is committed to providing equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, or any other characteristic protected by federal, state or local law. Mini Med will provide reasonable accommodations for qualified individuals with disabilities.

This company participates in the federal E-Verify program.