Senior NPD Supplier Quality Engineer - Onsite CT

Medtronic plc; North Haven (CT); Hybrid; USD 98,000 - 148,000; Full time

Benefits offered by this job

Competitive salary

Flexible benefits

Job summary

Medtronic North Haven, CT is seeking a Senior Quality Engineer to join the New Product Development quality team within the Surgical Operating Unit. The role focuses on manufacturability, inspection and assembly, supplier collaboration, and PPAP qualification to ensure robust processes and uninterrupted supply through design transfer.

You will lead supplier selection, monitor manufacturing cycles, manage NCMRs, support process validation, CAPA, and cross-functional design transfer activities,

Qualifications

• Bachelor’s degree in engineering or related technical field with a minimum of 4 years of relevant experience, or advanced degree with at least 2 years.
• Extensive understanding of manufacturing processes for plastics, metals, electronics and/or product level assembly.
• Regulatory knowledge in a regulated environment (FDA, ISO 13485, ISO 14971).
• Strong analytical and problem-solving skills with the ability to conduct root cause analysis.
• Excellent written and verbal communication skills with cross-functional collaboration abilities.

Responsibilities

• Supplier selection and qualification ensuring delivery of quality parts, materials and services.
• Monitor parts from acquisition through manufacturing cycle and resolve supplier-related issues.
• Evaluate supplier capabilities to meet product, process, quality and business requirements.
• Manage Non-Conformance Material Reports (NCMRs) for material and production issues.
• Manage supplier change requests, reporting and project management.
• Oversee Approved Supplier List including audits and supplier acceptance.
• Qualify materials via PPAP including process validation and technical writing.
• Drive supplier performance improvement and reduce escapes via CAPA and quality reviews.
• Oversee Process validation (IQ/OQ/PQ) and Master Validation Planning.
• Statistical analysis of manufacturing process performance; oversee FMEA and DFx activities.
• Collaborate cross-functionally to capture process controls in design transfer and DFx activities.
• Use project management to ensure supplier processes support engineering builds and design verification.
• Occasional travel to suppliers in the US and internationally.

Job description

Medtronic North Haven, CT is seeking a Senior Quality Engineer to join the New Product Development quality team within the Surgical Operating Unit. The role focuses on manufacturability, inspection and assembly, supplier collaboration, and PPAP qualification to ensure robust processes and uninterrupted supply through design transfer.

You will lead supplier selection, monitor manufacturing cycles, manage NCMRs, support process validation, CAPA, and cross-functional design transfer activities,