Risk Management Quality Engineer I New Product Development (Surgical)

We anticipate the application window for this opening will close on - 12 Aug 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Medtronic a global leader in medical technology services and solutions isseekinga Risk ManagementQuality Engineer to join our innovative role will be in the surgical operating unit within the new product development quality team.

The ideal candidate will have a strong interest inrisk management product development designcontrolsand regulatory compliance within the medical device position requiresa strong teamplayer who is a self-starter inquisitive and a fast learner.This position plays a critical role in the development of medical devices ensuring patient safety is embedded throughout the product lifecycle.

Key Responsibilities:

• Develop andmaintaincomprehensive strategies for risk management activities including:

• Collaborating cross-functionally to ensure the utmost product quality for patient safety

• Creating andmaintainingthe risk management file including therisk management plans and reports as well as conducting regular risk reviews.

• Leadinghazardand riskanalysisactivitiestoidentifypotential risks and implement effectiverisk controlmeasures.

• LeadingDesignFailure Modes and Effects Analyses (DFMEAs) in collaboration with project teams to systematically evaluate potential failure modes and their impacts.

• Analyzing and reviewing product complaints toanticipateand prevent future issues.

• Integratingproduct security measures to protect against potential vulnerabilitiesinto the risk management file.

• Participating in Process FMEA/User FMEA development and integrating the Process FMEA/User FMEA into the risk management file.

• Leading design review andmaintainingthe risk management file throughout the product lifecycle

• Developing and managing post-market surveillance plans tomonitorproduct performance and safety in the field.

• Leading field issue evaluation(includingroot cause analysis risk evaluation product containment strategy) duringinitiallaunch.

• Ensuring traceability between risk management file requirements and design outputsutilizinga requirements management tool

• Evaluate the safety risk implications of design changes

Other potential responsibilities:

• Collaborate with cross-functional teams to define and implement engineeringand statisticalprocesses that ensure product quality and compliance throughout the product lifecycle.

• Ensure compliance with relevant regulatory requirements including FDA ISO(e.g. 14971 FDA Part 820) and other international standards andparticipatein regulatory audits and inspections.

• Overseedesignvalidation anddesignverification activitiesof user needs and design inputs including the development of test plans protocolstestmethodsand reports.

• Ensure thorough andaccuratedocumentation including test results risk assessments and reports.

MinimumRequirements:

• Bachelors degree in engineering or a related technical field

Preferred Qualifications:

• Experience in medical devices pharmaceuticals or combination products

• Familiarity with medical device risk management standards (e.g. ISO 14971 concepts)

• Prior involvement in New Product Development (NPD) environments

• Background in Quality Engineering Risk Management R&D Systems Engineering or similar roles

• Clinical knowledge or experience supporting clinical risk assessment

• Experience using Minitab or other statistical analysis software

• Certification or experience with Design for Six Sigma / Design for Reliability methodologies

• Strong written verbal and digital communication skills

• Proficiency with Microsoft Office tools (Excel Word PowerPoint)

• Certifications:Certified Quality Engineer (CQE) Six Sigma Green Belt or equivalent certification AAMI design control certificationis preferred.

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

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.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.

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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):$66400.00 - $99600.00

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

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 findhere 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.