Senior RandD Engineer

Join our innovative, patient-focused Research and Development team as a Sr. RandD Engineer at Endologix! WHO WE ARE: Endologix LLC is a California-based global medical device company dedicated to improving patients lives through innovative therapies for the interventional treatment of vascular disease. Our therapeutic portfolio addresses clinically relevant unmet needs, spanning from abdominal aortic aneurysms to lower limb peripheral vascular disease. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician trainingsupported by industry-leading clinical evidence. At Endologix, were driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health. What sets us apart is not just our technology, but our culture. At Endologix, we foster a forward-thinking, mission-driven environment where every team member plays a vital role in advancing patient care. Our core values guide how we operate. As for our people? We empower them with the tools, trust, and continuous learning they need to grow. If youre passionate about making a meaningful difference in healthcare, youll find purpose and belonging here. Our Core Values are the guiding principles informing our choices and actions, because our customers and patients depend on us: - Patient Outcomes Drive Us: We improve lives with every advancement we deliver. - Integrity Defines Us: We do whats right, stay transparent, prioritize quality, and own our actions. - Innovation Advances Us: We stay curious, adaptable, and push boundaries. - Boldness Propels Us: We take smart risks and are unafraid in our pursuit of excellence. - Collaboration Unites Us: We partner across teams and with physicians to drive exceptional results. ABOUT THE ROLE: Were looking for a Sr. RandD Engineer to join our Research and Development team. In this role, youll 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. RandD 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 Endologixs innovation and business objectives. WHAT YOU'LL DO: - 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 (VandV), 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 companys quality system, maintaining audit readiness and full traceability in support of reg latory 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 toolingbalancing 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 RandD, 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.