Principal Quality Engineer Post Market Risk

We anticipate the application window for this opening will close on - 19 Dec 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

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 within the Robotic Surgical Technologies business.

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 :

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)

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

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

• Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and / or research and development as they apply to product or process quality.

TECHNICAL SPECIALIST CAREER STREAM : An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates delivers and / or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy : Recognized expert managing large projects or considerable latitude in determining deliverables of assignments with limited oversight from reviews and delegates work to lower level specialists.

Organizational Impact : Contributes to defining the direction for new products processes standards or operational plans based on business strategy with a significant impact on work group manage large projects or processes that span outside of immediate job area.

Innovation and Complexity : Problems and issues faced are difficult moderately complex and undefined and require detailed information gathering analysis and solutions to moderately complex problems and / or makes moderate to significant improvements of processes systems or products independently to enhance performance of job solutions to problems.

Communication and Influence : Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various negotiate with others to reach understanding or agreement and influence decision-making.

Leadership and Talent Management : Typically provides guidance coaching and training to other employees within job manages major / moderately complex projects involving delegation of work and review of work products at times acting as a team leader.

Required Knowledge and Experience : Requires a Baccalaureate degreeand minimum of 7 years of relevant experience OR Masters degree with a minimum of 5 years relevant experience OR PhD with 3 years 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) : $119200.00 - $178800.00

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

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.

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 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.

Required Experience :

Staff IC

Key Skills

Cruise,Law Enforcement,Attorney At Law,Business Sales,AC Maintenance,Architecture

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 119200 - 178800