Sr Principal R/D Engineer

Medtronic; Irvine (CA); On-site; USD 150,000 - 180,000; Full time

Job summary

Medtronic in Irvine, CA is seeking a Sr. Principal R&D Engineer to lead the design, development, and refinement of stent-based neurovascular devices. You will drive cross-functional efforts with Quality, Manufacturing, Regulatory Affairs, Clinical, and Marketing to ensure compliant and high-performing products.

The role emphasizes technical leadership, mentorship, and strategic direction to advance portfolio objectives in a regulated medical technology setting. Onsite with travel <10%.

Qualifications

• Bachelor's degree with 10+ years of relevant experience, or higher degrees with fewer years.
• Experience leading engineering projects in a regulated environment.
• Experience supporting product lifecycle, design changes, and CAPA activities.
• Experience developing technical documentation and executing verification/validation.
• Experience collaborating with cross-functional stakeholders to deliver objectives.

Responsibilities

• Lead engineering activities and influence design of new products or processes with significant impact.
• Implement strategic goals established by functional leadership.
• Set or influence long-range operational plans for the job area.
• Drive complex investigations, root cause analyses, and CAPAs tied to product performance and feedback.
• Partner with Quality, Manufacturing, Regulatory Affairs, Clinical, Supply Chain, and Marketing to implement enhancements.
• Develop and execute test plans, verification activities, and validation strategies.
• Author, review, and approve technical documentation including design history files and risk management.
• Serve as technical SME during audits, regulatory inspections, and cross-functional decisions.
• Mentor engineers and promote engineering excellence and best practices.

Skills

Engineering leadership

Regulated industry experience

CAPA and quality systems

Technical documentation

Cross-functional collaboration

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.

A s a Sr. Principal R&D Engine er, 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.
• Experie