At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

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 Medtronics 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:

• Bachelors 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 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.

Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.

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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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

About Medtronic

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 95000 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.

Learn more about our business mission and our commitment to diversity here.

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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.