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

• Lead and mentor teams in the development implementation and maintenance of quality assurance processes and standards.

• Collaborate with cross-functional teams including R&D manufacturing NPD and regulatory affairs to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle.

• Conduct risk assessments and manage risk mitigation activities in accordance with ISO 14971 and other applicable standards.

• Ensure compliance with all relevant regulatory requirements including FDA ISO and other international standards and participate in regulatory audits and inspections.

• Oversee validation and verification activities including the development of test plans protocols and reports to ensure that products meet specified requirements.

• Ensure thorough and accurate documentation of quality assurance activities including test results risk assessments and compliance reports.

Design Validation and Verification Responsibilities

• Define and manage systems requirements to ensure clarity completeness and testability. Collaborate with the system engineering team to define refine and manage system level requirements to ensure alignment with customer needs clarity completeness and testability.

• Oversee the requirements management process to ensure traceability and compliance. Responsible for verifying all design requirements are present and appropriately incorporated int risk management documentation.

• Develop and maintain critical to quality (CTQ) matrices to identify key product characteristics and ensure they meet customer needs and regulatory requirements ensuring traceability between them.

• Lead project teams in the testing of Clinician requirements of devices and products. Including development of protocols reports and execution of the Design Validations.

Risk Management Responsibilities

• Develop and manage risk management plans and reports and conduct regular risk reviews.

• Collaborate with the system engineering team to define thorough hazard analysis to identify potential risks and mitigate them effectively.

• Conduct Failure Modes and Effects Analysis (FMEAs) to systematically evaluate potential failure modes and their impacts in collaboration with project teams.

• Analyze and review product complaints to predict and prevent future issues.

• Collaborate with the system engineering team to define detailed risk analysis to ensure all potential risks are identified and mitigated.

• Ensure product security measures are implemented and maintained to protect against potential vulnerabilities.

• Develop and manage post-market surveillance plans to monitor product performance and safety in the field.

• Maintain and curate risk logs to ensure accurate and up-to-date risk documentation.

Minimum Requirements

• Bachelors degree in Engineering or a related technical field and 7 years relevant experience or a Master Degree and 5 years of relevant experience.

Nice to have

• Certifications: Certified Quality Engineer (CQE) Six Sigma Green Belt or equivalent certification is preferred.

• Experience: Experience in Quality Assurance Engineering

• Industry Experience: Medical device industry.

• Technical Skills: Proficient in systems engineering methodologies quality assurance practices risk management and regulatory compliance.

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.

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.