New · posted Oct 27
Medtronic · Medical Devices
Principal Quality Engineer
- Grand Rapids, MI
- On-site
- Full-time
- Senior & Principal
The role
We anticipate the application window for this opening will close on - 31 Dec 2026
Principal Quality Engineer for Medtronic, Inc. in Grand Rapids, MI. Responsible for products in the form of finished medical devices by supporting manufacturing operations and evaluating compliance of materials and processes with product specifications, regulatory requirements, and customer requirements. Coordinate Quality Engineering for medical device components, ensuring that all finished good and processes meet specifications. Leverage Good Manufacturing Practices (GMP) standards, navigate government and medical device regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, EU Medical Device Regulation (MDR), and State of the Art (SOTA). Coordinate and support internal and external audits conducted at the facility. Conduct Risk Assessments, Preliminary Hazard Analysis (PHA), and Process Failure Modes and Effects Analysis (PFMEA). Responsible for Non-Conformances, Complaints, and Corrective and Preventive Actions (CAPA). Utilize Process Improvement tools, including Define, Measure, Analyze, Improve, and Control (DMAIC), Root Cause Analysis (RCA), 5 Whys, Fishbone, and cause mapping. Contribute to Business Value stream Mapping (VSM) initiatives and support process flow strategy areas to drive quality excellence and process compliant stability. Coordinate Design of Experiments (DOE) methods for process development and statistical analysis tools for process capability (Cpk/Ppk), ANOVA, Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, and Test Method Validation (TMV). Coordinate V&V (verification and validation) protocols, including Installation Qualification, Operational Qualification, Performance Qualification (IQ, OQ, and PQ). Utilize analytical tools including Minitab and Power BI for statistical analysis and data-driven decision-making. Coordinate product lifecycle mgmt. efforts, including overseeing quality systems and authoring technical documentation. Leverage First Time Quality (FTQ) principles to enhance process improvement and drive strategic initiatives. Position is required to be onsite in Grand Rapids, MI, at least 4 days a week. Relocation assistance is not available for this position. .
What you need
Basic Qualifications
Master’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management or related engineering field and five (5) years of experience as a Quality or Packaging Engineer or related occupation in quality engineering;
Bachelor’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering management or related engineering field and seven (7) years of experience as a Quality or Packaging Engineer or related occupation in quality engineering.
Must possess at least five (5) years’ experience with each of the following:
GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR (or its predecessor), and SOTA; Risk Assessments, PHA, and PFMEA; Non-Conformances and CAPA; DMAIC, RCA, 5 Whys, Fishbone, cause mapping, and VSM; DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV; Lean – Six Sigma; V&V protocols and IQ/OQ/PQ; Minitab and Power BI; Product lifecycle mgmt., including quality systems and authoring technical documentation; and FTQ principles.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to 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), and 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.
Further details are available at the link below:
Pay and benefits
$121,000 – $181,200 a year
Employer providedSalary: $121,000 to $181,200 per year
Health, dental and vision insurance
401(k) with employer contribution and match
Paid time off and paid holidays
Employee Stock Purchase Plan
Tuition assistance/reimbursement
Incentive plans
Where you'll work
Grand Rapids, MIOn-siteOpen in Maps (opens in a new tab)
More jobs in Grand Rapids, MIEqual opportunity, accessibility and legal noticesMedtronic's statements, word for word
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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
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If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected].
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
This role's midpoint is 24% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Michigan15 roles publishing pay
Senior & Principal roles in the US323 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $121,000 | — | $181,200 |
| Michigan (middle half) | $104,000 | $119,000 | $119,000 |
| All US (middle half) | $104,000 | $122,000 | $142,250 |
This role: Medtronic's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 961 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Medtronic's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 10 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance2
- Documentation and SOPs2
- Investigations and CAPA2
- Validation and qualification2
- Regulatory submissions2
- Quality systems and risk2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
Company hiring pulse
Medtronic on Regulatory Jobs
- 21
- Open roles
- 17
- Distinct roles
- 11
- Locations
By discipline
- Quality14 67%
- Regulatory7 33%
By level
- Senior & Principal15 71%
- Manager3 14%
- Associate & Specialist3 14%
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Principal Quality Engineer at Medtronic
Applications close December 31. $121K–$181K a year, employer provided.