Lean Engineer (Medical Devices)

Location: Irvine, California, United States; full-time onsite position with regular presence on the manufacturing floor. Schedule flexibility is required for multiple shifts, time studies, audits, training, occasional overtime, weekend work, and off-shift coverage. Travel up to 5% may be required.

Salary: $90,000–$125,000 per year

Company

hirify.global is a medical technology company developing the iLet Bionic Pancreas, an insulin delivery system for type 1 diabetes management.

What you will do

• Conduct time and motion studies to establish cycle times, takt-time requirements, labor standards, and production capacity.
• Balance production lines, analyze staffing and constraints, monitor output and bottlenecks, and support real-time resource allocation.
• Improve line layouts, workstation configurations, standardized work, visual controls, ergonomics, and material flow.
• Lead or support Lean improvement activities including value-stream mapping, Kaizen, 5S, waste analysis, visual management, and setup reduction.
• Use production metrics, Lean Six Sigma, DMAIC, root-cause analysis, and statistical methods to reduce variation and recurring issues.
• Partner with Quality and Engineering on quality-system approvals, new product introductions, ramp-up, process transfers, project tracking, and employee training.

Requirements

• Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, Operations, or a related field, or equivalent education and experience.
• 3–5 years of experience in manufacturing engineering, industrial engineering, operational excellence, or continuous improvement.
• Strong knowledge of Lean manufacturing, waste elimination, production flow, time studies, work measurement, line balancing, capacity analysis, and labor planning.
• Experience translating production data and shop-floor observations into measurable improvements, with strong analytical, statistical, project-management, and problem-solving skills.
• Working knowledge of quality systems and regulatory requirements in regulated manufacturing; FDA, ISO 13485, GMP, or similar experience is preferred.
• Proficiency in Microsoft Excel and data-analysis tools; Minitab, Power BI, ERP, or Manufacturing Execution Systems experience is preferred.

Nice to have

• Lean Six Sigma certification, preferably Green Belt or higher.
• Medical-device or other regulated-industry experience.
• Experience facilitating Lean and Six Sigma projects, training teams, and implementing standardized work.

Culture & Benefits

• Mission-driven, collaborative environment with experienced colleagues and opportunities for meaningful impact.
• Medical and dental coverage.
• FSA and HSA plan options, including an annual company HSA contribution.
• 401(k) program with employer match.
• Vacation accrual and paid holidays.
• Work across office, production, laboratory, clean-room, and warehouse environments; personal protective equipment may be required.