Manufacturing Engineer II

Tandem Diabetes Care•Ruth, CA

1d•$85,000 - $102,000•Onsite

About The Position

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. Manufacturing Engineer II's are also responsible for: 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 involving mechanical components, electrical systems, and integrated assemblies. 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 and DHR) and bill of materials (BOM). Ensure compliance with FDA QSR and ISO 13485. Support 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. Develop and deliver 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. Collaborate with Quality to support nonconformances, CAPAs, audits, and regulatory inspections. Partner with Supply Chain to resolve supplier-related issues, support material changes, and improve incoming quality. Evaluate and implement design or process changes to address field issues, complaints, or obsolescence. Support 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. Other responsibilities as assigned.

Requirements

Awareness of federal and other regulations, e.g. QSRs, ISO 14971 IEC 60601 series.
Knowledge of Good Documentation Practices (GDP).
Familiar with product specifications, test specifications, process specifications.
Some integration experience in a manufacturing environment, to assist with design transfers to manufacturing.
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
B.S. degree in Engineering (Mechanical, Biomedical, Electrical) or a related field, or equivalent combination education and applicable job experience.
3 years of experience in medical device manufacturing.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

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

Responsibilities

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 involving mechanical components, electrical systems, and integrated assemblies.
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 and DHR) and bill of materials (BOM).
Ensure compliance with FDA QSR and ISO 13485.
Support 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.
Develop and deliver 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.
Collaborate with Quality to support nonconformances, CAPAs, audits, and regulatory inspections.
Partner with Supply Chain to resolve supplier-related issues, support material changes, and improve incoming quality.
Evaluate and implement design or process changes to address field issues, complaints, or obsolescence.
Support 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.
Other responsibilities as assigned.