Principal R&D Engineer
Endologix LLC · Santa Rosa, CA · 4 mo ago
Engineering$145k–$168k/yrFull-time
About the role
The Principal R&D Engineer is responsible for providing subject matter expertise and engineering leadership in the development of Aortic and Peripheral Vascular technologies including enhanced and new stent graft and catheter-based delivery systems to ensure achievement of Endologix goals and objectives.
Responsibilities
- Drive technology and product development from early concept through commercialization, maintaining a strong focus on delivering meaningful, real-world impact.
- Lead the design and execution of rigorous testing strategies, including experimental design, data analysis, and clear scientific reporting to support confident decision-making.
- Partner closely with R&D, Manufacturing, Regulatory, and Quality teams to investigate and resolve technical challenges, ensuring timely and effective solutions.
- Provide technical leadership with clear, professional communication across all levels, while ensuring all work is accurately documented in compliance with GMP and applicable procedures.
- Collaborate with engineers, machinists, and QA to develop innovative designs for new products, enhancements, and tooling solutions.
- Plan and execute testing activities to confirm designs meet defined specifications, performance expectations, and quality standards.
- Evaluate failure modes and conduct detailed technical risk analyses to strengthen product reliability and performance.
- Maintain thorough and compliant documentation in alignment with the company’s quality system and regulatory expectations.
- Guide and support technicians and, when needed, lead cross-functional teams to achieve shared project goals.
- Lead and contribute to cross-functional project teams, effectively managing resources and priorities to deliver successful outcomes.
- Proactively identify hazards and mitigate risks using structured approaches such as Design and Process FMEA.
- Manage complex projects across multiple disciplines, defining scope, setting objectives, and applying structured problem-solving to ensure efficient execution.
- Apply thoughtful judgment and calculated risk-taking to overcome technical challenges and drive projects forward.
- Oversee project budgets responsibly, ensuring effective use of resources while meeting project objectives.
- Collaborate with New Product Development teams to support component qualification and ensure readiness for production.
- Take on additional responsibilities as needed to support team success and evolving organizational priorities.
Qualifications
- Education: Bachelor's degree in Mechanical Engineering, Bioengineering from a four-year college or university; or related major in Life Sciences preferred.
- Experience: 11+ years of relevant experience with a Bachelor's degree, or 9+ years of relevant experience with a Master's degree, or 6+ years of relevant experience with a PhD in medical device manufacturing, development, testing, test plans, test reports, design control regulation and experience with catheter and stents.
- Skills/Competencies: Product Development, Testing & Validation, Engineering Design, Risk Analysis, Quality Compliance, Team Leadership, Project Planning, Cross-functional Collaboration, Decision Making & Risk Taking, Communication, Collaboration, Documentation, Problem Solving, Adaptability.