Sr Design Quality Engineer

COV Covidien LP; United States; On-site; USD 98,000 - 148,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) Plan with match

Tuition assistance

Job summary

Medtronic is seeking a Senior Design Quality Engineer in the Acute Care & Monitoring (ACM) Operating Unit to ensure product quality, reliability, and regulatory compliance across the ACM portfolio.

You will partner with R&D, regulatory, manufacturing, and program teams to apply design controls, risk management, and change control in release activities for medical device improvements. Strong collaboration and problem solving are essential.

Qualifications

• Bachelor’s degree required; 4+ years quality experience for senior level with a Bachelor’s.
• 2+ years quality experience with a Master’s degree.
• Experience in medical device industry or regulated environments.
• Working knowledge of ISO 13485, FDA QSR 21 CFR 820, and EU MDR.
• Experience applying ISO 14971 risk management.
• Familiarity with medical electrical equipment standards (IEC 60601).
• Experience with design controls, V&V planning, and test execution.
• Experience with CAPA and root-cause analysis.

Responsibilities

• Review new and modified designs for impact on requirements, safety, reliability, and compliance.
• Ensure changes align with QMS and global regulations.
• Lead risk management activities including DFMEAs and Risk Management Reports.
• Support verification and validation strategies and test documentation.
• Provide QA support across electrical, software, mechanical, optical domains.
• Collaborate with R&D, Regulatory, Operations, and Marketing on compliant changes.
• Apply DFSS, design for reliability and manufacturability concepts.
• Drive continuous improvement to product quality and manufacturing robustness.
• Mentor engineers on quality principles and design controls.

Skills

Quality engineering

Regulatory compliance

Cross-functional leadership

Design controls

Risk management

CAPA

Communications

Education

Bachelor’s Degree

Master’s Degree

Tools

ISO 13485

FDA QSR 21 CFR 820

EU MDR

IEC 60601

Job description

We anticipate the application window for this opening will close on - 18 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life The Senior Design Quality Engineer, supporting Released Product Engineering (RPE) within the Acute Care & Monitoring (ACM) Operating Unit, drives product quality, reliability, and regulatory compliance through technical expertise and cross‑functional leadership. This role partners with R&D, regulatory, manufacturing, and program teams to ensure design changes and sustaining engineering activities meet internal quality standards and global regulatory requirements. The Senior Design Quality Engineer plays a critical role in applying Design Controls, Risk Management, and Change Control processes to evaluate, implement, and release product improvements across the ACM product portfolio. If you are passionate about solving complex technical problems, improving product quality, and collaborating across disciplines to deliver safe and reliable medical devices, this role offers an opportunity to make meaningful impact.

Key Responsibilities

• Critically review new and modified product designs to evaluate impact on product requirements, patient safety, reliability, and regulatory compliance.
• Ensure design changes are executed in accordance with Medtronic’s Quality Management System (QMS) and applicable global regulations including ISO 13485, EU MDR, and FDA Quality System Regulation (21 CFR Part 820).
• Lead cross-functional teams in the development and maintenance of risk management documentation including Risk Management Plans, hazard analyses, DFMEAs, and Risk Management Reports in accordance with ISO 14971.
• Support development and review of verification and validation strategies, including test plans, protocols, and reports, ensuring alignment with product requirements and applicable standards.
• Provide quality engineering support for sustaining engineering initiatives across multiple technical domains including electrical, software, mechanical, optical, algorithms, and human factors.
• Collaborate with cross-functional partners including R&D, Operations, Regulatory Affairs, Marketing, and Program Management to ensure timely and compliant execution of product changes.
• Apply Design for Reliability, Manufacturability, and Design for Six Sigma (DFSS) methodologies to improve product performance and reduce risk.
• Drive continuous improvement initiatives that enhance product quality, reliability, and manufacturing robustness.
• Provide technical guidance and mentorship to engineers on quality engineering principles, risk management practices, and design control requirements.

MUST HAVE: MINIMUM REQUIREMENTS

• Education Required: Bachelor’s Degree.
• Years of Experience: Senior Level: 4+ years of Quality experience with a Bachelors Degree.
• 2+ years of Quality experience with a Masters Degree.
• Specialized Skills or Experience: Experience in the medical device industry or in a regulated industry with similar quality and regulatory requirements.
• Working knowledge of Quality Management Systems compliant with ISO 13485, FDA Quality System Regulation (21 CFR 820), and EU MDR.
• Experience applying risk management processes in accordance with ISO 14971.
• Familiarity with IEC 60601 and other applicable medical electrical equipment or product-specific standards.
• Experience supporting design controls, verification and validation planning, and test execution for medical device products.
• Experience with CAPA, root cause investigation, and failure analysis methodologies.
• Technical experience with electronic hardware systems, including PCB design, schematics, circuit analysis, and PCB assembly documentation.
• Demonstrated experience leading or owning complex technical problems or cross functional projects.
• Strong written and verbal communication skills with the ability to work effectively across cross functional teams.

NICE TO HAVE

• ASQ certifications (CQE, CRE, CQA, etc.)
• Experience with statistical methods including hypothesis testing, ANOVA, GR&R, sampling plans, and parametric/non parametric analysis.
• Experience using statistical software (Minitab or equivalent).
• Familiarity with reliability and environmental testing including HALT/HASS, shipping validation, sterilization, stability, or biocompatibility testing.
• Experience with Lean, DMAIC, or DFSS methodologies.
• Lean Six Sigma Green Belt or Black Belt.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long‑term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$98,400.00 - $147,600.00 This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

• 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)
• 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

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.