Senior Production Engineer (Medical Devices)

Location: Irvine, California, United States; onsite

Salary: $95,000–$130,000 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

• Design, develop, and implement efficient, cost-effective, safe, and compliant manufacturing processes and procedures.
• Monitor production KPIs including yield, scrap, downtime, and cycle time, and 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 multiple production-related projects and collaborate with engineering, quality, maintenance, supply chain, technicians, operators, and managers.
• Communicate with customers, suppliers, and other stakeholders to support product quality and customer satisfaction.

Requirements

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering, or equivalent education and applicable experience.
• 5–8 years of experience in a medical device environment.
• Experience with medical devices or consumer electronics and FDA, GMP, and ISO environments.
• Knowledge of quality system regulations and Good Manufacturing Practices, including ISO 13485 and FDA 21 CFR Part 820.
• Ability to use hand tools and operate electrical and mechanical equipment; interpret mechanical drawings and electrical schematics.
• Ability to work independently and collaborate effectively in cross-functional teams.

Culture & Benefits

• Mission-driven, collaborative culture with a high degree of empowerment.
• 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.
• Some extended hours and travel of up to 5% may be required depending on business needs.