Senior Medical Device Design Quality Engineer

Medtronic plc; Memphis, Northern (TN, KY); Hybrid; USD 115,000 - 148,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

401(k) with employer match

Tuition assistance/reimbursement

Well-being program (Simple Steps)

Paid time off

Employee Stock Purchase Plan

Job summary

Medtronic plc is seeking an engineer to develop and evaluate medical device designs aligned with regulatory standards. You will use DMAIC and DRM methods to improve manufacturability and cost, and verify performance with rigorous test methods.

Responsibilities include ensuring QMS compliance, risk management per ISO 14971, and collaboration across functions on product transfers and lifecycle activities.

Qualifications

• Master’s degree required with 2+ years in quality, product, or validation engineering.
• Experience with DMAIC, DOE, SPC, FMEA, and ISO 14971.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, GDP.
• Experience with IQ/OQ/PQ, CAPA and RCA.

Responsibilities

• Develop and evaluate designs meeting defined medical device requirements and optimize for manufacturability and cost.
• Verify design functionality by developing test methodologies and specifications.
• Ensure compliance with FDA/ISO QMS and global regulatory expectations.
• Collaborate with cross-functional teams on lifecycle management and transfer projects.

Skills

DMAIC methodology

DFR/DFM (Design for Reliability & Man.

Education

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

Tools

Minitab

MS Project

Job description

Medtronic plc is seeking an engineer to develop and evaluate medical device designs aligned with regulatory standards. You will use DMAIC and DRM methods to improve manufacturability and cost, and verify performance with rigorous test methods.

Responsibilities include ensuring QMS compliance, risk management per ISO 14971, and collaboration across functions on product transfers and lifecycle activities.