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

Responsibilities may include the following and other duties may be assigned.

Serves as Subject Matter Expert for Risk Management across the Post-Market space for their assigned product families

Accountable for and owns the Risk Management Files for assigned product families

Maintains Risk Management Files for assigned product families

Conducts product Risk Analysis (PHA RAC SSRCI/System & Use FMEAs) in compliance with ISO14971

Evaluates product Risk Management Files against field data to ensure accuracy and correctness of predicted risks; validating pre-market Benefit Risk Analysis and updating the Risk Management Files (RMF) as necessitated

Initiates and manages Product Hold Orders (PHOs) based upon production and field issues working with cross-functional teams to develop comprehensive and evidence-based disposition plans

Initiates and drives Post-Market Issue Evaluations (PMIE) and Health Risk Assessments (HRA) to closure based upon production and field issues taking into consideration inputs from cross-functional teams

Initiates and serves as owner/lead for Field Corrective Actions (FCAs) based upon HRA decision working alongside Enterprise FCA team

Supports post-market regulatory body and competent authority engagements including but not exclusive to:

o Post-Market Surveillance Report (PMSR) Periodic Safety Update Report (PSUR) Clinical Evaluation Report (CER) Summary of Safety and Clinical Performance (SSCP) Clinical Evaluation Plan (CEP) and Requests For Additional Information (RFAI)

Reviews and endorses Production Post-Production Risk Assessments (PPPRAs) for Change Development Projects (CDPs) as Risk Management SME

Consults on New Product Development programs during the Product Transfer to ensure Risk Management Files readiness for post-market. Including review of Risk Management Report (RMR) and Post-Market Surveillance Plan (PMSP).

Supports and collaborates with Post-Market Vigilance team to investigate complaints into potential adverse trends and aids in the early signal detection of field issues

MINIMUM QUALIFICATIONS

Requires a Bachelors degree in an engineering math or science discipline

For degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A)

Minimum of 6 years of combined experience in quality engineering or a related function or an advanced degree with a minimum of 4 years of combined experience in quality engineering or a related function

SPECIALIZED SKILLS OR EXPERIENCE

Risk Management experience in the medical device industry

Risk Management File lifecycle accountability

Statistical analysis tools and techniques

Significant breadth and depth in quality decision making risk management quality engineering reliability engineering and writing for compliance.

Knowledge and expertise in FDA 21 CFR 820 & 806 EU MDR (Regulation (EU) 2017/745) ISO 14971 ISO 24971 IEC 60812 and ISO 13485

NICE TO HAVE

Experience in engaging with Regulatory Agencies and customers / clinicians

DRM or Six Sigma Certification

Experience with complex capital equipment or disposable medical devices or medical device software

Reliability Engineering test experience

Typically has deep domain expertise and applies extensive engineering and industry expertise

Knowledge of IEC 62366-1 IEC 60601-1 IEC 62304 IEC 82304 BS/AAMI 34971

TRAVEL REQUIREMENTS

Occasional visits to product manufacturing and design centers as well as potential visits to Regulatory Bodies as needed. <10%

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.