Manufacturing Engineer II

Manufacturing Engineer II – San Diego, CA

Provides sustaining engineering and equipment support for commercialized medical device products, ensuring stable manufacturing performance, high product quality, and regulatory compliance. Responsible for troubleshooting manufacturing issues, leading root cause investigations, and driving continuous improvement initiatives with minimal oversight. Participates in manufacturing development planning and execution for prototype, pilot, and production design transfer.

• Independently troubleshoot manufacturing, process, and equipment issues impacting yield, quality, or throughput.
• Lead root cause investigations (RCA) and implement effective actions using structured problem‑solving methodologies (5
  
  Whys, Fishbone, DOE) for complex electro‑mechanical failures.
• Analyze manufacturing performance data (yield, scrap, downtime) and lead continuous improvement initiatives for electro‑mechanical assembly processes.
• Evaluate, procure, and support manufacturing equipment. Develop and execute IQ/OQ/PQ validations.
• Manage engineering changes (ECOs) to update and maintain manufacturing documentation (DMR, DHR) and bill of materials (BOM).
• Ensure compliance with FDA QSR and ISO
  13485. Support supplier and lifecycle‑management activities for electro‑mechanical components.
• Participate in Kaizen events, Lean Manufacturing, Six Sigma initiatives to improve yield, optimize process efficiency, reduce costs, and shorten lead times.
• Develop and deliver training to manufacturing personnel on electro‑mechanical assembly processes, test procedures, and equipment operation.
• Collaborate with Quality to support nonconformances, CAPAs, audits, and regulatory inspections. Partner with Supply Chain to resolve supplier‑related issues and support material changes.
• Evaluate and implement design or process changes to address field issues, complaints, or obsolescence. Support complaint investigations and failure analysis.
• Ensure compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Other responsibilities as assigned.

• Knowledge of federal and industry regulations (QSRs, ISO
  14971, IEC
  60601 series) and Good Documentation Practices.
• Familiarity with product specifications, test specifications, and process specifications.
• Experience with validation and change control.
• Root cause analysis and problem‑solving skills.
• Good analytical and organizational skills; ability to prioritize workload.
• Skilled at presenting information clearly to all levels within the department.
• Ability to react to changing situations calmly and confidently.
• Familiarity with manufacturing equipment systems.
• Solid Works or Pro/E (3D modeling knowledge). Basic knowledge of DFM.
• Working knowledge of PLM systems.

• B.S. degree in Engineering (Mechanical, Biomedical, Electrical) or related field, or equivalent combination of education and applicable work experience.

• Three (3) years of experience in medical device manufacturing.

• Lean Manufacturing experience;
  Green or Black Belt certification.
• Design of Experiment and Statistical Analysis.
• Process development, semi‑automation with embedded software, Agile PLM Software.
• ERP/MES experience.

The base annual salary ranges from $85,000 to $102,000, based on experience, location, and market. Additional compensation includes performance bonuses and a comprehensive benefits package: medical, dental, vision, health‑saving accounts, 11 paid holidays, at least 20 days PTO, 401(k) with company match, and Employee Stock Purchase Plan.

On‑site at our San Diego manufacturing facility. Monday‑Friday, 8:00AM–5:00PM PST.

Tandem is firmly committed to being an equal‑opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion, gender identity, marriage/civil partnership, pregnancy/maternity, or sexual orientation.

Applicants must be authorized to work for any employer in the U.S. Tandem is unable to sponsor or take over sponsorship of an employment visa at this time.