Senior Manufacturing Engineer (Medical Devices)

TL;DR

Senior Manufacturing Engineer (Medical Devices): Designing, optimizing, and sustaining manufacturing processes for regulated medical device production with an accent on process validation, statistical process control, lean manufacturing, and operational excellence. Focus on developing efficient production layouts, solving equipment and quality issues, improving yield and OEE, and ensuring compliance with applicable regulations.

Location: Onsite in Santa Ana, California, United States, five days per week. Candidates below Principal level must have unrestricted U.S. work authorization at the time of hire and throughout employment.

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

Company

hirify.global develops healthcare technologies and medical devices used to alleviate pain, restore health, and extend life.

What you will do

• Design manufacturing processes, production layouts, equipment arrangements, operating sequences, and material-handling procedures.
• Adapt machinery and equipment designs to factory and production conditions while incorporating inspection and testing requirements.
• Develop statistical process control methods and manufacturing processes that support consistent product performance.
• Inspect machinery, equipment, and tools; investigate deficiencies; and initiate corrective actions to improve quality and efficiency.
• Partner with Operations, Quality, R&D, Sourcing, and Packaging across product lifecycle activities.
• Lead validation strategy and execution, improve yield, quality, and OEE, and mentor junior engineers.

Requirements

• Bachelor’s degree with at least 4 years of relevant experience, or a master’s degree with at least 2 years of relevant experience, or a PhD with no experience required.
• Experience designing, optimizing, and sustaining manufacturing processes in a regulated medical device environment.
• Strong knowledge of lean manufacturing, structured problem solving, process validation, and advanced manufacturing technologies.
• Unrestricted U.S. work authorization is required; sponsorship is not available for this Senior-level role.
• International 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 translating complex drawings into manufacturing controls.
• Experience with laser welding, precision bonding, molding, extrusion, or micro-machining.
• DOE, multivariate analysis, advanced SPC, capability studies, MSA, metrology, and gage calibration.
• Maintenance strategies, PFMEA updates, reliability improvements, and high-volume production equipment.
• Cleanroom contamination control, particulate reduction, and environmental monitoring.

Culture & Benefits

• Onsite collaboration and cross-functional professional development.
• Health, dental, and vision insurance, plus HSA and healthcare FSA options for eligible regular employees.
• 401(k) with employer contribution and match, paid time off, paid holidays, and disability coverage.
• Tuition assistance, life insurance, employee assistance, and employee stock purchase plan.
• Incentive plans and access to a global well-being program.