Principal Mechanical Design Engineer

MiniMed•Los Angeles, CA

2d•$109,000 - $185,000•Hybrid

About The Position

MiniMed is seeking a Principal Mechanical Process Development Engineer for its Mechanical Engineering R&D Process Development group. The role leads new product and process development and design transfer activities for electromechanical medical devices, including insulin pumps, glucose sensors, and related accessories. It works at the intersection of product design, process development, and manufacturing to establish robust, scalable processes and support successful transfer from R&D to manufacturing. The position calls for extensive experience in new product introduction, process development, validation (IQ/OQ/PQ), test method development, and design transfer. The successful candidate will apply statistical analysis and data-driven methods, including Design of Experiments (DOE), regression analysis, ANOVA, process capability analysis, and Gage Repeatability and Reproducibility (GR&R), to solve technical problems. In a Hardware R&D environment, the role collaborates with Design Engineering, NPI, Manufacturing, PMO, Quality, and Regulatory teams to resolve technical challenges, meet milestones, and deliver business objectives. This is a hybrid role based in Northridge, California, with three days on-site. Travel to supplier and manufacturing sites may be required.

Requirements

Bachelor of Engineering degree and at least 7 years of experience in mechanical product and process development, or a Master of Engineering degree and at least 5 years of experience in mechanical product and process development.

Nice To Haves

Experience designing components for diabetes devices, such as insulin pumps, continuous glucose monitors, or infusion sets, or similar wearable or 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, including leading design reviews and ensuring timely completion of Design Control deliverables.
Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, MDD, and EU MDR.

Responsibilities

Lead product and process development for electromechanical medical products, identifying key process inputs, outputs, controls, and noise factors using Six Sigma tools.
Lead design transfer activities to ensure products transition successfully to manufacturing.
Apply Design for Reliability and Manufacturing (DRM), Design for Six Sigma (DFSS), and Design for Manufacturing Assembly / Automation (DFM/A) during product and process design and development.
Lead and perform process characterization, design characterization testing, and Test Method Validation (TMV).
Support equipment selection, tooling and fixture design, procurement, installation, and qualification.
Use CAD tools such as SolidWorks and apply GD&T and mechanical stack-up tolerance analysis.
Apply risk management methods, including dFMEA, pFMEA, and hazard analysis.
Work with manufacturing to assess the feasibility of high-volume assembly early in the development cycle.
Work with suppliers to ensure components meet design requirements and diagnose design and process problems.
Present technical findings and project status to cross-functional teams and management through meeting minutes, design reviews, presentations, and other communication methods.
Travel to supplier and manufacturing sites as required.

Benefits

Competitive salary and flexible benefits package.
Health, dental, and vision insurance for eligible regular employees working 20 or more hours per week.
Health Savings Account and Healthcare Flexible Spending Account.
Life insurance and long-term disability leave.
Dependent daycare spending account.
Incentive plans.
401(k) plan with company match.
Short-term disability coverage.
Paid time off and holidays.
Employee Stock Purchase Plan.
Employee Assistance Program.
Eligible employees may have access to a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.