Principal Mechanical Design Engineer
MiniMed
Summary
MiniMed is looking for a Principal Mechanical Process Development Engineer. As a member of the Mechanical Engineering R&D Process Development group, the successful candidate will lead new product and process development and design transfer activities for electromechanical medical devices, including insulin pumps, glucose sensors, and related accessories. This role operates at the intersection of product design, process development, and manufacturing, ensuring robust, scalable processes and a successful transition from R&D to manufacturing.
Job description
The ideal candidate will bring extensive experience in new product introduction, process development, validation (IQ/OQ/PQ), test method development, and design transfer to manufacturing. The candidate will be a proven technical problem solver with a strong foundation in statistical analysis and data driven decision making, including Design of Experiments (DOE), regression analysis, ANOVA, process capability analysis, and Gage Repeatability and Reproducibility (GR&R). Working within a dynamic Hardware R&D environment, this individual will collaborate cross-functionally with Design Engineering, NPI, Manufacturing, PMO, Quality, and Regulatory teams to resolve complex technical challenges, achieve milestones, and deliver on key business objectives. This is a hybrid role in Northridge, CA (3 days on-site).
Responsibilities
- Drive and lead product and process development activities of electromechanical medical products by identifying key process inputs, outputs, controls, and noise factors by effective utilization of Six Sigma tools
- Drive and lead design transfer activities ensure that products are transitioned to manufacturing successfully
- Apply methodologies such as Design for Reliability and Manufacturing (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly / Automation (DFM/A) during product / process design and development phase
- Lead and perform process characterization, design characterization testing, and Test Method Validation (TMV) activities
- Help with equipment selection, tooling and fixture design, procurement, installation, and qualification
- Demonstrated proficiency with CAD tools such as SolidWorks, GD&T, and mechanical stack up Tolerance Analysis
- Deep knowledge of risk management (dFMEA, pFMEA and hazard analysis)
- Work with manufacturing to ensure feasibility of high-volume assembly in early phase of development cycle
- Work with suppliers to ensure components meet design requirements & diagnose design / process problems
- Present technical findings or project status to cross functional teams and management through meeting minutes, design reviews, presentations, and other means of communication.
- Travel to supplier and manufacturing sites as required
Must Have: Minimum Requirements
- Bachelor of Engineering degree and 7+ years of experience in mechanical product and process development OR Master of Engineering degree and 5+ years of experience in mechanical product and process development
Nice to Have
- Experience designing components for diabetes devices (insulin pumps, CGMs, infusion sets) or similar wearable/implantable medical devices
- Experience with plastic injection molding, stamping, machining, extrusion, and related processes
- Formal training and certification in Six Sigma methodologies
- Experience with low and high-volume manufacturing
- Understanding of medical device design controls; lead design reviews and ensure on-time completion of Design Control deliverables
- Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, MDD & EU MDR.
Requirements
- Bachelor of Engineering degree and 7+ years of experience in mechanical product and process development OR Master of Engineering degree and 5+ years of experience in mechanical product and process development
- Experience in new product introduction, process development, validation (IQ/OQ/PQ), test method development, and design transfer to manufacturing
- Strong foundation in statistical analysis and data driven decision making, including Design of Experiments (DOE), regression analysis, ANOVA, process capability analysis, and Gage Repeatability and Reproducibility (GR&R)
- Proficiency with CAD tools such as SolidWorks, GD&T, and mechanical stack up Tolerance Analysis
- Deep knowledge of risk management (dFMEA, pFMEA and hazard analysis)
- Experience with equipment selection, tooling and fixture design, procurement, installation, and qualification
- Experience with Six Sigma tools and methodologies
- Experience with Design for Reliability and Manufacturing (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly / Automation (DFM/A)
- Experience with process characterization, design characterization testing, and Test Method Validation (TMV)
- Experience working with suppliers to ensure components meet design requirements and diagnose design / process problems
- Experience with high-volume assembly feasibility
- Experience presenting technical findings to cross functional teams and management
- Experience designing components for diabetes devices (insulin pumps, CGMs, infusion sets) or similar wearable/implantable medical devices
- Experience with plastic injection molding, stamping, machining, extrusion, and related processes
- Formal training and certification in Six Sigma methodologies
- Experience with low and high-volume manufacturing
- Understanding of medical device design controls; lead design reviews and ensure on-time completion of Design Control deliverables
- Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, MDD & EU MDR
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-Term Disability Coverage
- Dependent Daycare Spending Account
- Incentive Plans
- 401(k) With Company Match
- Short-Term Disability Coverage
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-Qualified Retirement Plan Supplement
- Capital Accumulation Plan
Company overview
MiniMed is a leading medical device company specializing in diabetes management technologies, with a rich history dating back to its founding in 1983 by visionary entrepreneur Alfred E. Mann. Originally acquired by Medtronic in 2001, MiniMed recently became an independent publicly-traded company in 2026, trading on Nasdaq under the ticker "MMED" with a market capitalization of approximately $5.29 billion. The company is headquartered in Northridge, California, and employs nearly 8,000 dedicated professionals focused on advancing diabetes care. MiniMed is unique as the only diabetes technology company that manufactures both insulin pumps and continuous glucose monitors (CGMs), offering integrated systems like the MiniMed 780G system with SmartGuard technology. Their flagship products include automated insulin delivery systems, continuous glucose monitoring sensors, and smart insulin pens designed to simplify diabetes management and improve patient outcomes. With a mission to make diabetes more predictable and manageable, MiniMed has established itself as a pioneer in diabetes technology, providing innovative solutions that help patients achieve better glucose control and enhance their quality of life.