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

We are seeking a highly skilled Risk Management Expert with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring product safety regulatory compliance and effective risk mitigation throughout the product lifecycle.

Develop and maintain comprehensive strategies for risk management activities including:

• Creating and managing risk management plans and reports as well as conducting regular risk reviews.
• Performing thorough hazard analyses to identify potential risks and implement effective mitigation measures.
• Leading Failure Modes and Effects Analyses (FMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts.
• Analyzing and reviewing product complaints to anticipate and prevent future issues.
• Conducting detailed risk analyses in conjunction with the system engineering team to ensure all potential risks are identified and addressed.
• Implementing and maintaining robust product security measures to protect against potential vulnerabilities.
• Developing and managing post-market surveillance plans to monitor product performance and safety in the field.
• Maintaining and curating risk logs to ensure accurate and up-to-date risk documentation

Other potential 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.
• 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.

Qualifications:

Minimum Requirements:

• Education: Bachelors degree in Engineering or a related technical field. Advanced degree preferred.
• Regulatory Knowledge: In-depth knowledge of FDA regulations ISO 13485 ISO 14971 and other relevant standards.
• Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
• Communication: Excellent written and verbal communication skills with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.
• Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.

Preferred Qualifications:

• Certifications: Certified Quality Engineer (CQE) Six Sigma Green Belt or equivalent certification is preferred.
• Experience: Experience in Quality Assurance Engineering Capital equipment
• Industry Experience: Medical device industry.
• Technical Skills: Proficient in 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.