Senior NPD Supplier Quality Engineer

Medtronic; North Haven (CT); On-site; USD 98,000 - 148,000; Full time

Job summary

Medtronic seeks a Senior Quality Engineer to join the Surgical Operating Unit, guiding design transfer, supplier qualification, and manufacturing process development. You will ensure process controls, validation, and continued readiness through PPAP and CAPA while interfacing with suppliers and internal teams.

This role requires experience in regulated environments, GD&T, FMEA, ISO 13485, and FDA knowledge, plus strong problem-solving and leadership to drive improvements across the supply chain

Qualifications

• Bachelor’s degree in engineering or a related technical field with 4+ years of relevant experience
• Experience in regulated environments; FDA/ISO knowledge
• Strong analytical and problem-solving skills with cross-functional collaboration

Responsibilities

• Qualify and monitor supplier quality and track parts through manufacturing cycle
• Lead PPAP activities including process validation and writing
• Manage non-conformance and supplier change requests with CAPA
• Perform statistical analysis of manufacturing process performance
• Collaborate with design controls and DFx to ensure transfer of design to manufacturing

Skills

Supplier management

Process validation

Regulatory knowledge

GD&T

FMEA

Problem solving

Communication

Leadership

Education

Bachelor’s degree in engineering

Advanced degree (optional)

Tools

SAP

Trackwise

Windchill

Agile

Job description

Medtronic seeks a Senior Quality Engineer to join the Surgical Operating Unit, guiding design transfer, supplier qualification, and manufacturing process development. You will ensure process controls, validation, and continued readiness through PPAP and CAPA while interfacing with suppliers and internal teams.

This role requires experience in regulated environments, GD&T, FMEA, ISO 13485, and FDA knowledge, plus strong problem-solving and leadership to drive improvements across the supply chain