We anticipate the application window for this opening will close on - 27 Jun 2025
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll 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. You'll 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 Unit's (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:
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)
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 Bachelor's 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 company's 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):$140,800.00 - $211,200.00
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 insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple 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 match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital 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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\name=signon&co\num=30601&co_affid=medtronic)
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 95,000+ 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 (http://www.medtronic.com) .
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.
If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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 95,000+ 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.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will...
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
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.
For sales reps and other patient facing field employees, going into a healthcare setting?is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
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