Manager, Manufacturing Engineering

About The Role

Tandem Diabetes Care is looking for an experienced Manufacturing Engineering Manager to lead manufacturing engineering of infusion sets, support both sustaining and new development efforts, and manage prototype, pilot, and production design transfer.

• Provide leadership and direction for Manufacturing Engineering.
• Responsible for all aspects of manufacturing engineering of infusion sets.
• Contribute to sustaining and new development efforts, including all aspects of new product introduction.
• Plan and execute manufacturing development for prototype, pilot, and production design transfer.
• Define, manage, and reduce product costs throughout the product lifecycle.
• Supervise a team of engineers and technicians in supplier, process, automation, failure analysis, and manufacturing engineering.
• Develop and define automated and manual assembly techniques, tooling, and contribute to electro/mechanical testing development.
• Direct troubleshooting on systems that cause or potentially cause work stoppage and reduce throughput times.
• Design and debug manufacturing test fixtures for subassemblies and train manufacturing staff on use.
• Support operations with the creation of BOMs, DMRs, DHFs, eDHRs, work orders, work instructions, test methods, product costs, and metrics.
• Create and measure applicable metrics such as cost, schedule adherence, and yield.
• Lead continual process improvement activities through Kaizen events, Lean Manufacturing, and Six Sigma to optimize process efficiency and reduce costs.
• Participate in Sustaining Engineering activities and design improvements to support improved manufacturability and testing.
• Review Process Capability Analysis (CpK) and develop equipment and process requirements, including validation protocols/reports.
• Execute DOE, IQ, OQ, PQ protocols, specify and validate test processes and equipment for external suppliers.
• Provide training and leadership on procedure, process, and equipment changes.
• Collaborate with Quality, R&D, and Design Engineering to facilitate the transition of new products and processes to manufacturing.
• Assist in transition and sustained production of new or existing processes/products with contract manufacturers.
• Analyze and assess vendor capability for development and high-volume manufacturing.
• Participate in selection, development, performance appraisal, merit recommendation, and promotion of department staff.

Hybrid:
Mix of in‑office work at the Barnes facility in San Diego, CA and remote. Expected in office 2–3 days per week, may vary based on business demands.

• Solid knowledge of Quality System Regulations (QSRs/GMPs).
• Proficient with MS Office and Solid Works; effective use of Word, Excel, PowerPoint for reporting and presentation.
• Understanding of product, test, and process specifications.
• Proven ability to drive quality and productivity improvements.
• Advanced integration experience in a manufacturing environment, assisting transfer of testing methodology to manufacturing.
• Excellent skills in cGMP documentation, writing policies, procedures, protocols, work instructions.
• Can manage multiple priorities, identify and recommend best actions, and make decisions based on overall team needs.
• Effective communication skills across functional areas and ability to lead a cooperative team effort.

• B.S. degree in Science or Engineering or a related field, or equivalent education and experience.
• 8+ years of medical device manufacturing experience.
• 3+ years of experience managing or leading manufacturing engineering staff.
• Experience in FDA/GMP/ISO environments.
• Lean Manufacturing and Six Sigma experience.
• Project Management experience.

The starting base pay range for this position is $142,000 – $177,000 annually, varying by knowledge, skills, and experience. Tandem also offers a competitive compensation package that includes bonus opportunities and a comprehensive benefits package.

• Health care benefits: medical, dental, vision available first day.
• Health savings accounts and flexible saving accounts.
• 11 paid holidays per year.
• Minimum of 20 days…