Senior MedTech Manufacturing Engineer — V&V & Transfers

Medtronic plc; Jacksonville (FL); On-site; USD 144,000 - 185,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

Health Savings Account (HSA)

Healthcare Flexible Spending Account (

Life Insurance

Long-term Disability Leave

Tuition Assistance/Reimbursement

401(k) with employer match

Paid Time Off

Job summary

Medtronic plc in Jacksonville, FL seeks a Principal Manufacturing Engineer to coordinate and execute site Verification and Validation (V&V) deliverables and oversee supplier transfers within the Transfer Office.

You will define Quality Impact Levels for supplier-qualified products and design fixtures, protocols, and reports while ensuring compliance with FDA 21 CFR part 820, EU MDR, ISO 13485, ISO 14971, and GMP.

Qualifications

• Master's or Bachelor's in mechanical/industrial/biomedical engineering or related field with 5–7 years in medical device manufacturing or design.
• Must have 5+ years’ experience with FDA 21 CFR part 820, EU MDR, ISO 13485, ISO 14971, and GMP; PPAP and IQ/OQ/PQ; Minitab, TMV, capability analyses, and SPC; Control Plans, PFMEA, and process documentation.

Responsibilities

• Coordinate and execute V&V deliverables for site.
• Manage supplier transfers within the Transfer Office.
• Develop protocols, reports, and sampling plans for top-level assembly tests.
• Update BOM structure in QMS and ensure regulatory compliance.

Skills

Regulatory compliance

Quality systems

Process optimization

Agile/SAP/ERP familiarity

Education

Master's degree in Mechanical/Industrial/Biomedical Engineering or related field

Bachelor's degree in Mechanical/Industrial/Biomedical Engineering or related field

Tools

Minitab

TMV

SPC

Ppk / Tolerance Intervals

QMS software

First Article Inspection tools

Job description

Medtronic plc in Jacksonville, FL seeks a Principal Manufacturing Engineer to coordinate and execute site Verification and Validation (V&V) deliverables and oversee supplier transfers within the Transfer Office.

You will define Quality Impact Levels for supplier-qualified products and design fixtures, protocols, and reports while ensuring compliance with FDA 21 CFR part 820, EU MDR, ISO 13485, ISO 14971, and GMP.