Sr Principal R/D Engineer

Medtronic; Irvine (CA); On-site; USD 161,000 - 241,000; Full time

Benefits offered by this job

Health, Dental and Vision

401(k) with company match

Paid time off

Tuition assistance

Job summary

Medtronic is seeking a Senior Principal R&D Engineer in Irvine, CA to lead the development and improvement of neurovascular stent-based devices. You will work with Quality, Manufacturing, Regulatory Affairs, Clinical, and Marketing to ensure product performance and lifecycle management, while aligning with regulatory requirements.

You will mentor engineers, drive complex problem solving, and lead design and validation activities in a regulated medical device environment.

Qualifications

• Bachelor's degree with 10+ years in engineering.
• Experience in regulated industry engineering projects.
• Experience with product lifecycle management and CAPA.
• Experience with technical documentation and V&V.
• Cross-functional collaboration with stakeholders.

Responsibilities

• Lead engineering activities shaping new products and processes.
• Drive complex investigations and CAPA related to product performance.
• Collaborate with Quality, Manufacturing, Regulatory Affairs, Clinical, Supply Chain, Marketing.
• Develop and execute test plans and validation strategies.
• Mentor engineers and provide technical leadership.

Job description

We anticipate the application window for this opening will close on - 25 Sep 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 95,000 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.

A Day in the Life

The Neuroscience Portfolio delivers therapies that treat disorders of the brain, spine, nerves, and vascular system. Through a broad range of medical technologies, our teams partner with physicians and healthcare systems worldwide to improve patient outcomes and quality of life.

Neurovascular Operating Unit

The Neurovascular Operating Unit develops technologies that treat acute ischemic stroke, hemorrhagic stroke, and other neurovascular diseases. Our portfolio includes devices designed to restore blood flow, remove clots, and treat complex vascular conditions, supporting physicians in delivering life‑changing therapies to patients worldwide.

This role supports the development, maintenance, and continuous improvement of stent-based neurovascular devices within a regulated medical technology environment. The engineering team partners closely with Quality, Manufacturing, Regulatory Affairs, Clinical, Supply Chain, and Marketing functions to ensure product performance, compliance, and lifecycle management are maintained while supporting patient outcomes.

This is an onsite position based in Irvine, California. Travel is expected to be less than 10% and may include visits to manufacturing sites, suppliers, or company locations as needed.

As a Sr. Principal R&D Engineer, you will serve as a recognized technical leader responsible for the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products. This role focuses on driving product improvements, resolving complex technical challenges, leading design and validation activities, and ensuring compliance with quality system and regulatory requirements. The position requires extensive cross-functional collaboration, technical mentorship, and strategic leadership to support product performance, business objectives, and long‑term portfolio success.

Primary Responsibilities

• Lead engineering activities and strongly influences the design of new products, processes, standards, or operational plans based on business strategy with a significant impact on functional results related to the development, maintenance, and continuous improvement of stent‑based neurovascular devices.
• Implements strategic goals established by functional leadership.
• Changes or may establish operational plans for job area with long‑range impact on results.
• Drive complex investigations, root cause analyses, and corrective and preventive actions (CAPAs) related to product performance, customer feedback, and field issues.
• Partner with Quality, Manufacturing, Regulatory Affairs, Clinical, Supply Chain, and Marketing teams to identify, evaluate, and implement product enhancements.
• Develop and execute test plans, protocols, verification activities, and validation strategies supporting product development, product updates, design changes, and performance improvements.
• Author, review, and approve technical documentation including engineering change orders, design history file documentation, risk management files, validation reports, and technical assessments.
• Serve as a technical subject matter expert during internal and external audits, regulatory inspections, and cross‑functional decision‑making activities.
• Mentor engineers and provide technical leadership on complex engineering challenges, promoting engineering excellence and best practices across the organization.

Required Qualifications

• Bachelor's degree with a minimum of 10 years of relevant experience OR Master's degree with a minimum of 8 years of relevant experience OR PhD with a minimum of 6 years of relevant experience.
• Experience leading engineering projects within a regulated industry environment.
• Experience supporting product lifecycle management, design changes, product investigations, and corrective and preventive action (CAPA) activities.
• Experience developing technical documentation and executing verification and validation activities.
• Experience collaborating with cross‑functional stakeholders to deliver technical and business objectives.

Preferred Qualifications

• Knowledge of FDA Quality System Regulations, ISO 13485, and medical device design control requirements.
• Experience conducting root cause investigations using structured problem‑solving methodologies.
• Experience supporting supplier management, manufacturing processes, and product transfer activities.
• Experience serving as a technical lead and mentoring engineers on complex engineering programs.
• Experience supporting commercially released products within a regulated manufacturing environment.

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 impact. In 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.

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):$160,800.00 - $241,200.00

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).

• 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
• Simple Steps (global well‑being program)

• 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)
• 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

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 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.