Manufacturing Engineer II (Medical Devices)

Location: Dexter, Michigan, United States; onsite five days per week with minimal travel.

Salary: $83,200–$124,800 per year for U.S. locations, excluding Puerto Rico and specific California locations.

Company

hirify.global develops healthcare technologies, including extracorporeal life support products and catheters that support patient care worldwide.

What you will do

• Develop, sustain, and improve production fixtures, equipment, inspection solutions, and manufacturing processes.
• Analyze process performance using DOE, SPC, hypothesis testing, capability studies, Gemba walks, and Lean manufacturing tools.
• Identify root causes, define corrective actions, and support yield improvement, quality enhancement, capacity expansion, and technology implementation projects.
• Create work instructions, train operators, and collaborate with equipment suppliers on process specifications, capability, and suitability.
• Specify, purchase, install, validate, and sustain manufacturing equipment using IQ/OQ/PQ activities.
• Manage project scope and timelines, prepare test plans and reports, and provide day-to-day production support.

Requirements

• Bachelor’s degree and at least 2 years of relevant experience, or a master’s degree with no required experience.
• Unrestricted U.S. work authorization is required at hire and throughout employment.
• For bachelor’s degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Ability to work onsite and collaborate with Quality, Regulatory, R&D, Operations, technicians, suppliers, and consultants.
• Ability to interpret technical drawings, specifications, engineering documentation, and manufacturing process requirements.

Nice to have

• Medical device or other regulated manufacturing experience.
• Quality System documentation and regulated process experience.
• Manufacturing automation, vision systems, or PLC-controlled equipment experience.
• Process and equipment validation experience, including IQ/OQ/PQ.
• Experience leading process improvements, cross-functional projects, root cause analysis, and corrective actions.

Culture & Benefits

• Five-day onsite work environment focused on in-person collaboration and professional growth.
• Health, dental, vision, life, and disability insurance options.
• Health Savings Account, Flexible Spending Account, dependent daycare spending account, and tuition assistance.
• 401(k) plan with employer contribution and match, paid time off, paid holidays, and employee stock purchase plan.
• Short-term incentive eligibility through the hirify.global Incentive Plan.