Jobs · Engineering · California

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.

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