Sr. R&D Engineer

Endologix•Santa Rosa, CA

2d•$100,000 - $115,000

About The Position

We’re looking for a Sr. R&D Engineer to join our Research & Development team. In this role, you’ll provide advanced technical leadership to support the lifecycle management, enhancement, and sustaining engineering of commercially available stent grafts and catheter-based delivery systems. This role drives design improvements, evaluates product performance, and ensures compliance with regulatory and quality system requirements to support product safety, reliability, and patient outcomes. In addition, the Sr. R&D Engineer contributes to the design and development of next-generation stent graft and delivery system technologies, supporting activities from concept and feasibility through verification, validation, and commercialization. Working cross-functionally with Quality, Regulatory, Manufacturing, Clinical, and physician partners, this role applies engineering expertise, analytical rigor, and sound judgment to solve complex technical challenges and advance Endologix’s innovation and business objectives.

Requirements

Bachelor's degree in Engineering discipline (Mechanical / Biomedical preferred) or equivalent experience.
5+ years of experience with a bachelor’s degree, 3+ years of experience with a Master’s degree, 15+ years of experience without an advanced degree.
Experience in medical device manufacturing, development, testing, or designing, GMP, FDA, and ISO requirements and experience writing protocols, test plans, test reports, design control regulation and experience with catheter and stents preferred.
Advanced Engineering Expertise: Strong foundation in mechanical and/or biomedical engineering principles with demonstrated experience in medical device design, verification and validation, and sustaining engineering activities.
Patient-Centered Design Mindset: Applies engineering rigor with a clear understanding that product performance, safety, and reliability directly impact patient outcomes; consistently prioritizes risk mitigation and clinical effectiveness.
Regulatory & Quality Systems Acumen: Deep working knowledge of FDA Quality System Regulations, ISO 13485, design controls, risk management (ISO 14971), and GMP requirements; demonstrates integrity through meticulous documentation and defensible data practices.
Experimental Design & Statistical Analysis: Proficiency in developing robust test strategies, applying statistical tools, interpreting complex datasets, and drawing sound technical conclusions to support regulatory submissions and engineering decisions.
Risk Assessment & Failure Analysis: Skilled in conducting FMEAs, root cause investigations, hazard analyses, and implementing effective corrective and preventive actions.
Innovation & Technical Curiosity: Demonstrates adaptability and creative problem-solving; challenges assumptions, explores new approaches, and advances product and process improvements while balancing technical and regulatory constraints.
Cross-Functional Collaboration: Effectively partners with R&D, Manufacturing, Quality, Regulatory, Clinical, and external stakeholders; fosters alignment and drives shared accountability for results.
Technical Leadership & Influence: Provides clear technical direction, mentors junior engineers and technicians, and confidently presents complex information to leadership and cross-functional teams.
Project & Time Management: Manages multiple priorities in a fast-paced development environment; delivers high-quality work within established timelines and project milestones.
Communication Excellence: Communicates technical concepts clearly and concisely in written reports, protocols, presentations, and cross-functional discussions.
Bold & Accountable Decision-Making: Exercises sound engineering judgment, takes thoughtful risks when appropriate, and owns outcomes with transparency and accountability.

Responsibilities

Lead the development and execution of rigorous, science-based testing strategies, drafting comprehensive test plans (e.g., experimental design, statistical analyses) and detailed reports that ensure design robustness, regulatory compliance, and ultimately improved patient outcomes.
Conceptualize, develop, validate, and continuously refine test methods to support product design, verification and validation (V&V), and global regulatory submissions, demonstrating integrity through accurate, transparent, and defensible data practices.
Partner with New Product Development (NPD) teams to support component qualification and the creation and maintenance of Product Development Process (PDP) deliverables (e.g., Design Specifications, FMEAs, Traceability Matrices), ensuring alignment with quality system requirements and design control standards.
Document all work in accordance with GMPs, SOPs, and the company’s quality system, maintaining audit readiness and full traceability in support of regulatory expectations and organizational integrity.
Provide technical leadership and clear direction while collaborating effectively with senior management, engineers, technicians, and cross-functional stakeholders to drive project milestones and successful commercialization.
Evaluate and influence designs for new products, product enhancements, components, assemblies, and tooling—balancing innovation with risk mitigation and manufacturability considerations.
Conduct thorough failure investigations, root cause analyses, and technical risk assessments to identify hazards and implement effective mitigations within Design and Process FMEAs.
Collaborate closely with R&D, Manufacturing, Regulatory, Quality, and Clinical teams to resolve complex technical issues, support sustaining engineering activities, and ensure continued product performance and safety in the field.
Proactively identify opportunities for product improvement, process optimization, and cost efficiencies while maintaining a bold yet thoughtful approach to risk and innovation.
Serve as a technical mentor to junior engineers and technicians, fostering a culture of curiosity, accountability, and continuous learning.
Engage with physician partners and external stakeholders, when appropriate, to ensure product designs reflect real-world clinical needs and deliver meaningful patient impact.
Perform additional responsibilities as assigned, supporting team objectives and advancing departmental and organizational goals.

Benefits

Base salary of $100,000/yr-$115,000/yr
Discretionary bonus
Equity participation as approved by Board of Directors (4-year vesting schedule)
Comprehensive health, dental, and vision insurance plans
Flexible Health Savings Accounts (HSAs) and/or Flexible Spending Accounts (FSAs)
Generous paid time off (vacation, sick leave, holidays, and flexible time off that is available for Exempt employees)
401(k) retirement plan with company match
Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
Employee recognition programs and awards
Commuter benefits or transportation stipends