Production Engineer - Weekend Shift (Medical Devices)

Location: Irvine, California, United States; full-time onsite position with regular presence on the manufacturing floor. Schedule: Friday through Sunday, primarily 8:00 a.m. to 8:00 p.m.

Salary: $85,000–$115,000 annually

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

• Design, develop, and implement manufacturing processes and procedures that meet product, quality, and safety requirements.
• Monitor yield, scrap, downtime, cycle time, equipment performance, and other production indicators; implement corrective actions.
• Develop process improvements and continuous improvement initiatives using Lean manufacturing principles and tools.
• Troubleshoot machinery, equipment, and software issues using root cause analysis and corrective action techniques.
• Coordinate production projects and collaborate with Engineering, Quality, Maintenance, Supply Chain, technicians, operators, managers, customers, and suppliers.
• Support compliance with GMP, ISO 13485, FDA 21 CFR Part 820, OSHA, and internal quality and safety requirements.

Requirements

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or equivalent education and applicable work experience.
• 2–5 years of relevant experience in a medical device manufacturing environment.
• Experience in medical device or consumer electronics manufacturing and in FDA-, GMP-, and ISO-regulated environments.
• Ability to apply Quality System Regulation and Good Manufacturing Practice principles.
• Ability to use hand tools, operate electrical and mechanical equipment, interpret test and process results, and read mechanical drawings and electrical schematics.
• Strong communication, teamwork, independent decision-making, attention to detail, and deadline management skills.

Culture & Benefits

• Mission-driven, collaborative environment with experienced colleagues and opportunities to make a significant impact.
• Comprehensive 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.
• Personal protective equipment may be required in production, laboratory, or controlled areas; travel may be required up to 5%.