Senior Design Quality Engineer – Medical Devices

Medtronic plc; Memphis (TN); On-site; USD 115,000 - 148,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

Health Savings Account

Healthcare Flexible Spending Account

Life Insurance

Long-term Disability Leave

Dependent daycare spending account

Tuition assistance/reimbursement

Simple Steps well-being program

401(k) plan with employer match

Employee Stock Purchase Plan

Employee Assistance Program

Capital Accumulation Plan

Job summary

Medtronic seeks a design-focused engineer to develop and evaluate medical device designs that balance manufacturability, reliability, and cost. You will verify performance through robust testing and apply DMAIC, DRP, and QMS principles while aligning with FDA and ISO requirements.

This role emphasizes risk assessment, CAPA/RCA, and document control across PSUR, CER, and TD files to support EU MDR and global markets. A Master’s degree and 2+ years of related experience are expected.

Qualifications

• Requires a Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related field.
• Minimum 2 years of experience as a quality, product or validation engineer.
• Experience with DMAIC, Minitab, DOE, SPC, FMEA, ISO 14971, QMS, FDA 21 CFR Part 820, ISO 13485, GDP, IQ/OQ/PQ, CAPA, RCA, PSUR, CER, TD files, EU MDR, PPAP, CP, PF, MR.

Responsibilities

• Develop and evaluate designs that meet defined medical device requirements and are optimized for manufacturability, reliability, and cost.
• Verify design performance with test methodologies and specifications.
• Ensure compliance with FDA/ISO regulatory requirements and contribute to global regulatory documentation.

Education

Master's degree in Mechanical, Industrial, or Biomedical Engineering

Tools

DMAIC

Minitab

DOE

SPC

Gage R&R

ANOVA

t-test

Regression analysis

Process Capability

Confidence & Tolerance interval

FMEA

ISO 14971

A3 thinking

PDCA

5 Whys

Ishikawa

QMS

CTQ identification

FDA 21 CFR Part 820

ISO 13485

GDP

IQ/OQ/PQ

CAPA

RCA

PSUR

CER

TD files

EU MDR

PPAP

CP

PF

MR

Job description

Medtronic seeks a design-focused engineer to develop and evaluate medical device designs that balance manufacturability, reliability, and cost. You will verify performance through robust testing and apply DMAIC, DRP, and QMS principles while aligning with FDA and ISO requirements.

This role emphasizes risk assessment, CAPA/RCA, and document control across PSUR, CER, and TD files to support EU MDR and global markets. A Master’s degree and 2+ years of related experience are expected.