Supplier Engineer - Electronics (Onsite - Acton, MA)

Key Responsibilities

• Serve as the day-to-day technical liaison between internal teams and suppliers for assigned components or projects
• Own execution of defined workstreams within supplier engineering projects (e.g., NPI, sustaining, Continuous improvement initiatives)
• Plan and execute engineering qualification activities with guidance; contribute to and review qualification documentation
• Track project timelines, risks, and deliverables, ensuring alignment with cross-functional partners
• Support and lead portions of technical investigations related to supplier or product issues
• Build and maintain effective working relationships with assigned suppliers
• Ensure compliance with medical device standards and internal quality systems
• Contribute to cost reduction, material changes, and product transfer activities
• Apply structured problem-solving tools (8D, 5 Whys, Fishbone) to identify root cause and implement corrective actions
• Develop and review process flows and support process validation activities (IQ/OQ/PQ)
• Perform and interpret statistical analyses (e.g., Gage R&R, SPC)

Minimum Qualifications

• Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related discipline
• 2–4 years of experience in supplier engineering, manufacturing engineering, quality engineering, or related field

Preferred Skills & Competencies

• Working knowledge of PCBA and/or battery manufacturing processes
• Experience supporting process validation (IQ/OQ/PQ)
• Experience with root cause analysis tools (8D, A3, Fishbone, 5 Whys)
• Proficiency with statistical tools (Gage R&R, SPC, basic DOE exposure)
• Ability to analyze data and recommend solutions for moderately complex issues
• Familiarity with FDA (21 CFR Part 820), ISO 13485, CAPA, GMP
• Understanding of PFMEA/DFMEA and CTQ concepts
• Exposure to Lean, Six Sigma, or continuous improvement methodologies
• Experience supporting: NPI projects, Product transfers, Cost savings or material changes