Sr Principal R/D Engineer

COV Covidien LP; Irvine (CA); On-site; USD 161,000 - 241,000; Full time

Benefits offered by this job

401(k) plan

Short‑term disability

Paid time off

Paid holidays

Employee Stock Purchase Plan

Employee Assistance Program

Job summary

Medtronic in Irvine, CA is seeking a Sr. Principal R&D Engineer to lead design, verification, and validation of stent‑based neurovascular devices. You will mentor engineers, drive CAPAs, and collaborate across Quality, Manufacturing, Regulatory, Clinical, Supply Chain, and Marketing to deliver compliant product enhancements.

The role emphasizes leadership, strategic planning, and compliance with FDA ISO requirements in a regulated environment, with travel <10% and onsite work in Irvine.

Qualifications

• Bachelor's degree with 10+ years in engineering leadership in a regulated industry.
• Experience leading engineering projects and managing product lifecycle changes.
• Experience developing technical documentation and executing verification/validation.
• Experience collaborating with cross-functional stakeholders to meet objectives.

Responsibilities

• Lead engineering activities and influence design of new products with cross‑functional impact.
• Implement strategic goals established by functional leadership.
• Drive complex investigations, root cause analyses, and CAPAs related to product performance.
• Partner with Quality, Manufacturing, Regulatory Affairs, Clinical, Supply Chain, and Marketing to implement improvements.
• Develop and execute test plans, protocols, verifications, and validations.
• Author/review design history files, risk management, and validation reports.
• Serve as SME during audits/regulatory inspections and cross‑functional decisions.
• Mentor engineers and promote engineering excellence.

Skills

Engineering leadership

CAPA experience

Regulatory compliance

Cross-functional collaboration

Technical mentorship

Education

Bachelor's degree

Master's degree

PhD

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. 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.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail].

Benefits & Compensation

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 pertain 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).

• 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.

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 settingis 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. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [e-mail] To request removal of your personal information from our systems please email [e-mail]