Design Quality Engineer II

The Design Quality Engineer II, supporting Released Product Engineering (RPE) within the Acute Care & Monitoring (ACM) Operating Unit, contributes to product quality, reliability, and regulatory compliance through quality engineering support for sustaining engineering and product change activities.

This role partners with R&D, Regulatory Affairs, Manufacturing, Operations, and Program teams to help ensure design changes and released product engineering activities are executed in accordance with Medtronic’s Quality Management System (QMS), applicable standards, and global regulatory requirements. The Design Quality Engineer II applies Design Controls, Risk Management, and Change Control processes to support evaluation, implementation, and release of product improvements across the ACM product portfolio.

If you are passionate about solving technical problems, improving product quality, and collaborating across functions to support safe and reliable medical devices, this role offers an opportunity to make meaningful impact while continuing to grow your design quality engineering expertise., * Review new and modified product designs to help assess impact to product requirements, patient safety, reliability, standards compliance, and regulatory requirements.

• Support design change activities in accordance with Medtronic’s QMS and applicable global regulations and standards, including ISO 13485, EU MDR, and FDA Quality System Regulation / QMSR expectations.
• Support the development and maintenance of risk management documentation, including Risk Management Plans, hazard analyses, DFMEAs, risk assessments, and Risk Management Reports in accordance with ISO 14971.
• Review and provide input to verification and validation strategies, test plans, protocols, reports, and supporting documentation to help ensure alignment with product requirements and applicable standards.
• Provide quality engineering support for sustaining engineering initiatives across technical disciplines such as electrical, software, mechanical, optical, algorithms, human factors, and data analysis.
• Collaborate with cross-functional partners including R&D, Operations, Regulatory Affairs, Marketing, Manufacturing, and Program Management to support timely and compliant execution of product changes.
• Support investigations, issue evaluation, CAPA activities, root cause analysis, and failure analysis as needed for released product quality concerns.
• Apply quality engineering tools and problem-solving methods to help identify risks, evaluate data, and support product and process improvements.
• Contribute to continuous improvement initiatives that enhance product quality, reliability, manufacturability, and compliance.
• Communicate technical and quality information clearly through documentation, review comments, meetings, and cross-functional collaboration.

• Bachelor’s degree in Engineering, Science, or a related technical discipline and a minimum of 2 years of relevant Engineering, Quality, or regulated industry experience; or an advanced degree with relevant academic, project, internship, or industry experience., * Experience in the medical device industry or another regulated industry with similar quality and regulatory requirements.
• Working knowledge of Quality Management Systems and regulated product development or sustaining engineering processes.
• Familiarity with ISO 13485, FDA Quality System Regulation / QMSR expectations, EU MDR, or other applicable medical device regulatory frameworks.
• Familiarity with risk management principles, including ISO 14971, hazard analysis, FMEA, or risk-benefit documentation.
• Experience supporting design controls, verification and validation activities, design changes, or product lifecycle documentation.
• Ability to review technical documentation and assess potential quality, safety, reliability, and compliance impacts.
• Experience supporting CAPA, root cause investigation, nonconformance evaluation, issue assessment, or failure analysis.
• Strong written and verbal communication skills with the ability to work effectively across cross-functional teams.
• Demonstrated ability to manage assigned tasks, document decisions clearly, and escalate issues appropriately.

Nice to Have

• Medical device design quality, sustaining engineering, released product engineering, or product development experience.
• Experience with electronic hardware systems, PCB assemblies, schematics, circuit analysis, or related technical documentation.
• Familiarity with IEC 60601 or other applicable medical electrical equipment/product-specific standards.
• Experience with statistical methods such as hypothesis testing, ANOVA, GR&R, sampling plans, or parametric/non-parametric analysis.
• Experience using statistical software such as Minitab or equivalent.
• Familiarity with reliability or environmental testing, including HALT/HASS, shipping validation, stability, sterilization, or biocompatibility testing.
• Experience with Lean, DMAIC, DFSS, or structured problem-solving methodologies.
• ASQ certification such as CQE, CRE, CQA, or equivalent quality certification.
• Lean Six Sigma Green Belt or Black Belt.

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):$79,200.00 - $118,800.00

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).

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:

Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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., About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future., If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.

We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world
• Grow a career reflective of your passion and abilities
• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting is 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.