Principal Mechanical Process Development Engineer (Medical Devices)

Location: Northridge, California, United States; hybrid with 3 days on-site

Salary: $109,000–$185,000 USD annually for California roles; a $147,000 U.S. salary range figure is also listed.

Company

hirify.global develops intelligent insulin delivery systems, predictive diabetes insights, and related support technologies.

What you will do

• Lead new product and process development for electromechanical medical devices, including insulin pumps, glucose sensors, and accessories.
• Drive design transfer from R&D to manufacturing and ensure robust, scalable, high-volume assembly processes.
• Lead process and design characterization, test method validation, equipment selection, tooling and fixture development, and qualification.
• Apply Six Sigma, DRM, DFSS, and DFM/A methods to identify process inputs, outputs, controls, and noise factors.
• Collaborate with Design Engineering, NPI, Manufacturing, PMO, Quality, Regulatory, and suppliers to resolve technical and process issues.
• Present technical findings and project status, and travel to supplier and manufacturing sites as required.

Requirements

• Bachelor of Engineering degree with 7+ years of mechanical product and process development experience, or Master of Engineering degree with 5+ years of such experience.
• Extensive experience with new product introduction, process development, validation including IQ/OQ/PQ, test method development, and design transfer to manufacturing.
• Strong technical problem-solving skills and experience with statistical analysis, DOE, regression analysis, ANOVA, process capability analysis, and GR&R.
• Proficiency with CAD tools such as SolidWorks, GD&T, and mechanical stack-up tolerance analysis.
• Deep knowledge of risk management, including dFMEA, pFMEA, and hazard analysis.
• Experience assessing manufacturing feasibility and working with suppliers to meet design requirements and diagnose design or process problems.

Nice to have

• Experience designing components for diabetes devices or similar wearable or implantable medical devices.
• Experience with plastic injection molding, stamping, machining, extrusion, and related processes.
• Formal Six Sigma training and certification.
• Experience with low- and high-volume manufacturing.
• Knowledge of medical device design controls and experience leading design reviews and completing Design Control deliverables on time.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, MDD, and EU MDR.

Culture & Benefits

• Full-time employment in a hybrid Northridge role with regular on-site work.
• Health, dental, and vision insurance, plus HSA and healthcare FSA access.
• Life insurance, disability coverage, dependent daycare FSA, paid time off, and holidays.
• 401(k) with company match, Employee Stock Purchase Plan, Employee Assistance Program, and additional retirement plans subject to eligibility.
• Compensation and benefits apply to candidates hired in the United States; local market compensation and benefits apply elsewhere.