Supplier Engineer Electronics Insulet
Overview
The Supplier Engineer – Electronics leads supplier engineering activities for medical device components. This role owns new product introductions process validations continuous improvement projects quality investigations and supplier performance support. The engineer collaborates with cross-functional teams and external suppliers to solve technical issues drive improvements and ensure compliance with medical device standards. This is an excellent opportunity for an engineer with experience in manufacturing quality or supplier engineering who enjoys working with suppliers leading projects and enhancing processes in a regulated environment.
What You'll Do11
- 1Serve as the day-to-day technical liaison between internal teams and suppliers for assigned components or projects
- 2Execute defined workstreams within supplier engineering projects such as NPI sustaining and continuous improvement initiatives
- 3Plan and conduct engineering qualification activities with guidance and review qualification documentation
- 4Track project timelines risks and deliverables aligning with cross-functional partners
- 5Lead technical investigations related to supplier or product issues and respond to operational escalations
- 6Maintain effective relationships with assigned suppliers
- 7Ensure compliance with medical device standards and internal quality systems
- 8Contribute to cost reduction material changes and product transfer activities
- 9Apply structured problem-solving tools like 8D 5 Whys and Fishbone to identify root causes and implement corrective actions
- 10Develop and review process flows supporting IQ/OQ/PQ activities
- 11Perform statistical analyses using Gage R&R SPC and basic DOE with moderate guidance
Requirements13
- 1Bachelor’s degree in Electrical Engineering Biomedical Engineering or related discipline preferred
- 22–4 years of experience in supplier engineering manufacturing engineering quality engineering or related field strongly preferred
- 3Experience executing engineering or cross-functional projects
- 4Ability to interface with suppliers or external partners
- 5Working knowledge of PCBA battery manufacturing processes
- 6Proficiency with process validation (IQ/OQ/PQ)
- 7Understanding of root cause analysis tools such as 8D A3 Fishbone 5 Whys
- 8Familiarity with statistical tools Gage R&R SPC basic DOE exposure
- 9Ability to analyze data and recommend solutions for moderately complex issues
- 10Exposure to FDA 21 CFR Part 820 ISO 13485 CAPA GMP
- 11Understanding of PFMEA DFMEA and CTQ concepts
- 12Experience with Lean Six Sigma or continuous improvement methodologies
- 13Support for NPI product transfers cost savings or material changes
Salary Insight
$70 - $106k per year
Location
Required Skills
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