Manufacturing Engineer II

About the role

Tandem Diabetes Care is seeking a Manufacturing Engineer II to join our dynamic team. This role provides sustaining engineering and equipment support for commercialized medical device products, troubleshooting manufacturing issues, leading root cause investigations, and driving continuous improvement initiatives.

Responsibilities

• Provides sustaining engineering and equipment support for commercialized medical device products, ensuring stable manufacturing performance, high product quality, and regulatory compliance.
• Troubleshoots manufacturing issues, leads root cause investigations, and drives continuous improvement initiatives with minimal oversight.
• Participates in manufacturing development planning and execution for prototype, pilot, and production design transfer.
• Independently troubleshoots manufacturing, process, and equipment issues impacting yield, quality, or throughput.
• Leads root cause investigations (RCA) and implement effective actions using structured problem-solving methodologies (5 Whys, Fishbone, DOE) for complex electro-mechanical failures involving mechanical components, electrical systems, and integrated assemblies.
• Analyzes manufacturing performance data (yield, scrap, downtime) and lead continuous improvement initiatives for electro-mechanical assembly processes.
• Evaluates, procures, and supports manufacturing equipment.
• Develops and executes IQ/OQ/PQ validations.
• Manages engineering changes (ECOs) to update and maintain manufacturing documentation (DMR and DHR) and bill of materials (BOM).
• Ensures compliance with FDA QSR and ISO 13485.
• Supports supplier and lifecycle management activities for electro-mechanical components, including PCBs, cables, batteries and mechanical subassemblies.
• Participates in continual process improvement activities through Kaizen events, Lean Manufacturing and Six Sigma designed to improve yield, optimize process efficiency, reduce costs and lead-times.
• Develops and delivers training to manufacturing personnel on electro-mechanical assembly processes, test procedures, and equipment operation.
• Supports R&D to aid in the transition of new products and processes to manufacturing.
• Collaborates with Quality to support nonconformances, CAPAs, audits, and regulatory inspections.
• Pairs with Supply Chain to resolve supplier-related issues, support material changes, and improve incoming quality.
• Supports complaint investigations and failure analysis, including electrical testing, mechanical teardown, and system-level diagnostics.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.

Requirements

• Knowledge of federal and other regulations, e.g., QSRs, ISO 14971 IEC 60601 series.
• Good analytical and organizational skills with the ability to prioritize workload.
• Skilled at presenting information in a clear, concise manner to all levels within the department.
• Skilled at contributing on a consistent basis to team initiatives in a thorough and timely manner.
• Able to react to changing situations in a timely, calm, and confident manner.
• Root cause analysis and problem-solving skills.
• Experience with validation and change control.
• Familiarity with manufacturing equipment systems.
• SolidWorks or Pro/E (3D modeling knowledge).
• Basic knowledge of DFM.
• Working knowledge of Product Lifecycle Management (PLM) system.
• ERP/MES experience.

Preferred Qualifications

• Lean Manufacturing Experience.
• Green or Black belt certification.
• Design of Experiment and Statistical Analysis.
• Experience in process development.
• Semi-automation experience with embedded software.
• Agile PLM Software.

What You'll Need

• Knowledge of Good Documentation Practices (GDP).
• Familiar with product specifications, test specifications, process specifications.
• Integration experience in a manufacturing environment, to assist with design transfers to manufacturing.

When & Where You’ll Work

This position is open to candidates in San Diego, California and will work onsite at our manufacturing facility. Equipment for the role will be provided, and training will occur onsite. Schedule: This position will work Monday - Friday from 8:00 AM - 5:00 PM PST.

Compensation & Benefits

The starting base pay range for this position is $85,000 to $102,000 annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package. Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts. You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan. Learn more about Tandem’s benefits here!