Senior Manufacturing Engineer (Medical Devices)

Location: Onsite in Irvine, California, United States; working onsite five days per week

Salary: $102,400–$153,600 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies focused on alleviating pain, restoring health, and extending life.

What you will do

• Design manufacturing processes, procedures, production layouts, equipment arrangements, and sequences of operations.
• Adapt machinery and equipment designs to factory and production conditions.
• Integrate inspection and testing requirements into production plans and develop processes suitable for statistical process control.
• Inspect machinery, equipment, and tools; investigate deficiencies and initiate corrective actions to protect product quality.
• Provide manufacturing and equipment guidance to engineering teams and support product performance requirements.
• Ensure manufacturing processes and procedures comply with applicable regulations while supporting Operations, Quality, R&D, Sourcing, and Packaging.

Requirements

• Bachelor’s degree and at least four years of relevant experience, or a master’s degree with at least two years of relevant experience, or a PhD with no experience required.
• Experience designing, optimizing, and sustaining manufacturing processes in a regulated medical device environment.
• Proficiency in lean manufacturing, structured problem solving, validation strategy and execution, and continuous improvement.
• Ability to improve operational KPIs including yield, quality, and OEE and mentor junior engineers.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment. U.S. sponsorship is offered only for Principal-level roles and above.
• Foreign bachelor’s degrees must meet the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• GD&T, tolerance stack-ups, and experience translating complex drawings into manufacturing controls.
• Experience with laser welding, precision bonding, molding, extrusion, or micro-machining in medical device manufacturing.
• DOE design, multivariate analysis, advanced SPC, control chart strategy, and capability studies.
• Maintenance strategies, PFMEA updates, reliability improvements, MSA, metrology, and gage calibration.
• Cleanroom contamination control, particulate reduction, and environmental monitoring experience.

Culture & Benefits

• Onsite collaboration and cross-functional professional development.
• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, and disability coverage.
• Paid time off, paid holidays, paid sick time where required, and employee assistance resources.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance or reimbursement and a global well-being program.