We anticipate the application window for this opening will close on - 31 Jul 2025

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

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 of a Post-Market Risk Quality Engineering Manager reporting to Director of Post-Market Risk Surgical Operating Unit.

Responsibilities may include the following and other duties may be assigned.
Plans manages and implements aspects of the Surgical Operating Units (SOU) Post-Market Risk Management of medical device products or software systems.
May develop evaluate implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials techniques or company products in support of Post-Market Risk
Leads the investigation and evaluation of risk of production and field issues.
Manages the Post-Market Risk Quality Engineers in support of identifying controlling and taking action to mitigate risks associated with existing commercialized product across the assigned product familiess
Organizes the coordination of activities with team members outside suppliers and consultants to ensure timely delivery.
Selects develops and evaluates personnel to ensure the efficient operation of the team.
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
Advises and coaches team on conducting and may conduct themself product Risk Analysis (PHA RAC) 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
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
Supports and may lead Field Corrective Actions (FCAs). Ensuring smooth collaboration and closure with Medtronic Enterprise team
Manages Product Hold Orders (PHOs) based upon production and field issues working with cross-functional teams to develop comprehensive and evidence-based disposition plans
Supports post-market regulatory body and competent authority engagements including but not exclusive to:
oPost-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)
Leads and may support team of Risk Quality Engineers evaluating and endorsing Production Post-Production Risk Assessments (PPPRAs) for Change Development Projects (CDPs)
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) for assigned product families.
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 5 years of combined experience in quality engineering or a related function or an advanced degree with a minimum of 3 years of combined experience in quality engineering or a related function. With an additional minimum of 2 years of managerial experience.

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%

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

• Plans directs and implements all aspects of the companys design and development of new medical device products or software systems.
• May develop evaluate implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials techniques or company products.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies materials machines processes or products.
• Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors documentation maintenance throughout all phases of research and development.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Selects develops and evaluates personnel to ensure the efficient operation of the function.

PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM:Management and supervisory professionals with one or more employees who are focused on tactical operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility managing performance developing talent engagement and inclusion communicating business and operational developments planning prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring developing and coaching staff on meeting/exceeding performance expectations and defined objectives providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets conducting performance reviews and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

DIFFERENTIATING FACTORS

Autonomy:Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments.
Provides tactical and / or operational leadership and coaching.
Receives assignments in task and objective oriented terms.

Organizational Impact:Establishes operational plans and implements policies and strategies.
Decisions impact program schedules customer satisfaction levels or allocation of time material resources expenditures and funds.
May have budget or P&L accountability for a department function or geography.
Strive for continuous improvement and consistency in deliverables.

Innovation and Complexity:Proposes modifications to functional operating policies and day-to-day processes.
Problems and issues faced are complex difficult and undefined and require detailed information gathering analysis and investigation to understand the problem.

Communication and Influence:Communicates with internal and external customers and vendors regarding ongoing operations.
Uses information exchange influence and active persuasion without direct exercise of command to gain cooperation of other parties .
May interact on issues that have externally shared objectives.

Leadership and Talent Management:Manages a team consisting of supervisors and / or experienced professionals in the Specialist career stream.
Leads directs and reviews the work of a team who exercise latitude and independence in their assignments.
Authorizes hiring firing promotion and reward within own area.

Required Knowledge and Experience:Requires practical knowledge in leading and managing the execution of processes projects and tactics within one job area.
Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
Requires a Baccalaureate degree (or 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) and minimum of 5 years relevant experience or advanced degree with a minimum of 3 years prior relevant experience.

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.

Salary ranges for U.S (excl. PR) locations (USD):$140800.00 - $211200.00

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