Sr Principal R/D Engineer
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
