Principal Quality Engineer

Regulatory Toolkit; Grand Rapids (MI); In loco; USD 121.000 - 181.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health, Dental and Vision insurance

Health Savings Account

Education assistance

Employee Stock Purchase Plan

Paid time off

Paid holidays

401(k) with employer match

Descrizione del lavoro

Medtronic, Inc. in Grand Rapids, MI is seeking a Principal Quality Engineer to oversee quality for finished medical devices and to support manufacturing operations for regulatory compliance and product certification.

You will coordinate quality engineering activities, drive CAPA, risk management, and process improvements, and apply advanced statistical methods using Minitab and Power BI to ensure compliant, high-quality products.

Competenze

• Master’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management or related field with five years in quality engineering.
• OR Bachelor’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management with seven years in quality engineering.
• Must have at least five years’ experience with GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR (or its predecessor), and SOTA.
• Experience with Risk Assessments, PHA, and PFMEA; Non-Conformances and CAPA.
• DMAIC, RCA, 5 Whys, Fishbone, and VSM experience; DOE, Cpk/Ppk, ANOVA, Gage R&R, TMV.
• Lean – Six Sigma familiarity; V&V protocols and IQ/OQ/PQ; Minitab and Power BI.
• Product lifecycle mgmt., including quality systems and authoring technical documentation.

Mansioni

• Coordinate Quality Engineering for medical device components to meet specifications.
• Support manufacturing operations and evaluate regulatory compliance (21 CFR 820, ISO 13485).
• Coordinate internal and external audits at the facility and support process improvement.
• Lead risk assessments (PHA) and DFMEA/PFMEA activities and CAPA management.
• Apply DMAIC, RCA, and statistical tools (Minitab) to drive process capability (Cpk/Ppk).
• Develop DOE studies and manage V&V protocols (IQ/OQ/PQ) and documentation.

Conoscenze

GMP & QSR

Risk Assessments (PHA, PFMEA)

CAPA & Non-Conformances

DMAIC & RCA

DOE & Statistics (Cpk/Ppk, ANOVA)

V&V IQ/OQ/PQ

Minitab & Power BI

Quality systems docs

Formazione

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

Bachelor’s degree in Biomedical/Mechanical/Industrial Eng or related field

Strumenti

Minitab

Power BI

Descrizione del lavoro

We anticipate the application window for this opening will close on - 31 Dec 2026

Position Description:

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. #LI-DNI.

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;

OR

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.

Salary:

$121,000 to $181,200 per year

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
• 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)
• 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:

Medtronic benefits and compensation plans