Principal Mechanical Design Engineer

We anticipate the application window for this opening will close on - 30 Oct 2026 At Mini Med, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

Mini Med 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.

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).

• 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 Solid Works, 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

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 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.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations…