Manager, Manufacturing Engineering

Responsibilities

Provides leadership and direction for Manufacturing Engineering. Oversees all aspects of manufacturing engineering for infusion sets, collaborating on sustaining and new development efforts, including new product introduction.

Planned and executes manufacturing development for prototype, pilot, and production design transfer. Defines, manages, and reduces product costs throughout the product life cycle.

Supervises a team of engineers and technicians supporting supplier, process, process automation, failure analysis, and manufacturing engineering.

Defines and implements automated and manual assembly techniques, tooling, and electro/mechanical testing development to improve manufacturability.

Directs troubleshooting to prevent or resolve systems that cause work stoppage and reduce throughput.

Designs and debugs manufacturing test fixtures, trains staff, and supports operations with BOMs, DMRs, DHFs, (e)
DHRs, work orders, work instructions, test methods, and product cost metrics.

Establishes metrics such as cost, schedule adherence, and yield; ensures product cost targets are met.

Initiates and leads continuous improvement activities through Kaizen, Lean Manufacturing, and Six Sigma to optimize efficiency, reduce costs, and shorten lead times.

Participates in Sustaining Engineering activities, including design improvements for manufacturing and testing, reviews Process Capability Analysis, and develops equipment and process validation protocols.

Conducts DOE, IQ/OQ/PQ testing, specifies and validates test processes and equipment for external suppliers, and reviews supplier capability.

Provides training and leadership on procedural, process, and equipment changes.

Collaborates with Quality and R&D to investigate failures, developing corrective and preventive actions using PFMECA, FMECA, DOE, and Fault Tree analysis.

Works closely with R&D and Design Engineering to transition new products and processes to manufacturing, developing production test plans, requirements, and specifications.

Assists Operations, Manufacturing, and Production leaders with prototype development planning and pilot build activities.

Collaborates with Contract Manufacturers on transition and sustained production of new or existing processes/products, evaluating vendor capability for development or high‑volume manufacturing.

Participates in staff selection, development, performance appraisal, merit recommendation, and promotion.

• Solid knowledge of Quality System Regulations (QSRs/GMPs) and cGMP documentation, including policies, procedures, protocols, work instructions, and inspection requirements.
• Proficiency with MS Office (Word, Excel, PowerPoint) and Solid Works.
• Strong analytical skills for cost, yield, and schedule metrics; experience leading quality and productivity improvements.
• Advanced manufacturing integration experience, including transfer of testing methodology to production.
• Experience managing multiple priorities, recommending best actions, and influencing cross‑functional decisions.
• Effective communication and presentation skills; ability to lead team efforts and coordinate resources.
• B.S. degree in Science or Engineering (or related field) or equivalent education and experience.
• 8+ years of medical device manufacturing experience, with 3+ years managing manufacturing engineering staff.
• Experience in FDA/GMP/ISO environments and proven Lean Manufacturing and Six Sigma expertise.
• Project Management experience.

Hybrid:
In‑office work at our Barnes facility in San Diego, CA or Irvine, CA combined with remote work. Expected in‑office 2‑3 days per week, but may vary with business demands.

• Base pay range: $142,000 – $177,000 annually, based on role, experience, and location.
• Bonuses and a comprehensive benefits package, including medical, dental, and vision coverage from day one.
• Health Savings Accounts and Flexible Spending Accounts.
• 11 paid holidays per year and at least 20 days of paid time off (accrual starts day one).
• 401(k) plan with company match and Employee Stock Purchase Plan.

Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. Selection for roles will be based on individual merit alone.