Manufacturing Engineer II (Medical Device)

TL;DR

Manufacturing Engineer II (Medical Device): Providing sustaining engineering and equipment support for commercialized medical device products with an accent on manufacturing performance, quality, and regulatory compliance. Focus on troubleshooting complex electro-mechanical failures, leading root cause investigations, and driving continuous improvement initiatives in a high-precision production environment.

Location: Must be based in San Diego, California and work onsite

Salary: $85,000 – $102,000 annually

Company

A leader in the diabetes technology industry dedicated to creating innovative, human-centered products for people living with diabetes.

What you will do

• Independently troubleshoot manufacturing, process, and equipment issues impacting yield and throughput.
• Lead root cause investigations for complex electro-mechanical failures using structured methodologies.
• Develop and execute IQ/OQ/PQ validations for manufacturing equipment.
• Manage engineering changes and maintain manufacturing documentation (DMR/DHR) and BOMs.
• Collaborate with R&D, Quality, and Supply Chain to support process improvements and material changes.
• Deliver training to manufacturing personnel on assembly processes and test procedures.

Requirements

• Must be authorized to work for any employer in the U.S. (no visa sponsorship available).
• Must be able to work onsite in San Diego, California.
• B.S. degree in Engineering (Mechanical, Biomedical, Electrical) or equivalent experience.
• Minimum 3 years of experience in medical device manufacturing.
• Knowledge of FDA QSR and ISO 13485 standards.
• Proficiency in SolidWorks or Pro/E and familiarity with PLM systems.

Nice to have

• Lean Manufacturing experience or Green/Black belt certification.
• Experience with Design of Experiment (DOE) and statistical analysis.
• Background in semi-automation with embedded software.
• Experience with ERP/MES systems.

Culture & Benefits

• Comprehensive health care benefits (medical, dental, vision) starting on day one.
• 401k plan with company match and Employee Stock Purchase plan.
• Minimum 20 days of paid time off plus 11 paid holidays.
• Health savings accounts (HSA) and flexible spending accounts (FSA).
• Inclusive workplace culture that values diversity and individual merit.