Sr. Design Quality Engineer

Medtronic; 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

We anticipate the application window for this opening will close on - 25 Nov 2026

Position Description:

Develop and evaluate designs which meet defined medical device product requirements and that are optimized for manufacturability, reliability, and overall cost to the business. Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements. Utilize project mgmt. and lean sigma methodologies, including Define, Measure, Analyze, Improve, and Control (DMAIC) & Design for Reliability and Manufacturability (DRM), MS Project and adhere to the applicable medical device FDA requirements for design and manufacturing, including medical device materials and related processes. Utilize design development, analysis and statistical tools including Minitab, and statistical methods including DOE (Design of Experiments), SPC (Statistical Process Control), Variable Gage R & R (Reliability and Repeatability), ANOVA (analysis of Variance), t-test, regression analysis, Process Capability, and Confidence & Tolerance interval analysis. Evaluate products and process risks using Failure Mode Effects Analysis (FMEA), utilizing ISO14971. Conduct QMS (Quality Mgmt. System) processes including CTQ (Critical to Quality) identification and leverage knowledge of FDA 21 CFR part 820, ISO 13485 and Good Documentation Practices (GDP). Utilize Lean sigma, including design capability, value stream and process mapping, and 5S. Troubleshoot production and other issues utilizing problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why's and Ishikawa (Fishbone). Execute Process Qualification including IQ (Installation Qualification), OQ (operation Qualification) and PQ (Performance Qualification) and perform safely. Leverage Corrective and Preventive actions (CAPA) with use of RCA (Root Cause Analysis) to solve problems, document conditions and create solutions to avoid future problems. Responsible for developing, contributing to, and maintaining Periodic Safety Update Reports (PSURs), Clinical Evaluation Reports (CERs), and Technical Documentation (TD files) in accordance with EU MDR (Medical Device Regulations) requirements. Collaborate with cross functional teams to ensure compliance with global regulatory expectations, support lifecycle mgmt. activities, and maintain up to date clinical, safety, and technical documentation for assigned products. Comply with Production Part Approval Process (PPAP) requirements documentation, including Control Plans (CP), Process Flow (PF), and Material Requirements (MR) for transfer projects. Relocation assistance is not available for this position. #LI-DNI.

Basic Qualifications:

Requires a Master's degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and 2 years of experience as a quality, product or validation engineer.

Must possess at least two (2) years of experience with each of the following:

• DMAIC methodology
• Minitab, DOE, SPC, Variable Gage R & R, ANOVA, t-test, regression analysis, Process Capability, and Confidence & Tolerance interval analysis
• Product and Process risk utilizing FMEA and ISO 14971, A3 thinking, PDCA, 5 Why's, and Ishikawa (Fishbone)
• QMS process, CTQ identification, FDA 21 CFR Part 820, ISO 13485, and GDP
• IQ/OQ/PQ, CAPA and RCA
• PSUR, CER and TD files as per EU MDR and global requirements
• PPAP, CP, PF, MR for transfer projects

Salary: $115,000 to $147,600 per year

Benefits (20+ hours per week regular employees):

• 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 (global well-being program)

Benefits (all regular employees):

• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Additional Information:

Further details are available at the link below: Medtronic benefits and compensation plans