Senior Supplier Quality Engineer, NPD (Onsite)

Medtronic plc; Lafayette (CO); On-site; USD 107,000 - 161,000; Full time

Benefits offered by this job

Health, Dental and vision insurance

401(k) plan with employer match

Tuition assistance

Job summary

Medtronic plc is seeking a Senior Quality Engineer to join the NPD team in the Surgical Operating Unit. You will influence design for manufacturability, qualify processes, and manage supplier relationships to ensure supply continuity during design transfer. A strong background in process controls, PPAP, and regulatory compliance is essential.

The role requires onsite work at multiple U.S. locations with travel to suppliers, and offers a broad benefits package while maintaining a patient-first

Qualifications

• Education: Bachelor’s degree in engineering or a related technical field and a minimum 4 years of relevant experience; advanced degree with 2+ years acceptable.
• Technical Knowledge: Deep understanding of manufacturing processes for plastics, metals, electronics and assembly; GD&T, FMEA, DFX.
• Regulatory Knowledge: Experience in a regulated environment with FDA regulations and ISO 13485/14971.
• Problem-Solving: Strong analytical and root-cause skills.
• Communication: Excellent written and verbal collaboration across teams.
• Leadership: Proven leadership and project management abilities.

Responsibilities

• Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services.
• Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
• Evaluate supplier technical and manufacturing capabilities to meet product, process, quality, and business requirements as an input to supplier selection.
• Manage Non-Conformance Material Reports (NCMRs) for material, components and production related issues, ensuring trends are identified, analyzed, and addressed across incoming, production, and sterilization areas.
• Manage suppliers' change requests, including communication, project management, and regular reporting.
• Manage the Approved Supplier List, from supplier evaluation, supplier agreement, supplier audits to supplier acceptance.
• Qualify materials through PPAP, including process validation, test method validation, technical writing, and project management.
• Drive supplier performance improvement and reduce escapes to manufacturing through effective issue escalation, CAPA management, and Quality Performance Reviews.
• Oversee Process validation (IQ/OQ/PQ) and Master Validation Planning in new product development.
• Perform Statistical analysis of manufacturing process performance outputs
• Oversee Process Failure Mode and Effects Analysis (internal and external)
• Collaborate cross functionally to ensure process limitations are captured within the design control, including DFMEA and DFM&A activities.
• Collaborate cross functionally to ensure essential components, product features and respective process controls are identified.
• Ensure Design Transfer translates design specs into production specs.
• Use project management to ensure supplier processes develop at the cadence to support engineering builds and V&V.
• The job requires occasional travel to visit suppliers within the United States and internationally.

Skills

CQE

Six Sigma

Problem solving

Leadership

Education

Bachelor’s degree in engineering or related technical field

Tools

SAP

Trackwise

Windchill

Agile

Job description

Medtronic plc is seeking a Senior Quality Engineer to join the NPD team in the Surgical Operating Unit. You will influence design for manufacturability, qualify processes, and manage supplier relationships to ensure supply continuity during design transfer. A strong background in process controls, PPAP, and regulatory compliance is essential.

The role requires onsite work at multiple U.S. locations with travel to suppliers, and offers a broad benefits package while maintaining a patient-first