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Endologix

Medical devices for durable vascular repair

Senior R&D Engineer

Biomedical Engineering & Medical DevicesPosted on Nov 5
Full-timeSanta Rosa, CA, USA$100k - $115k /yrIn-person

About the Job

Requirements

  • A bachelor's degree in an Engineering discipline or equivalent experience.
  • With a bachelor's degree, at least 5 years of experience; with a master's degree, at least 3 years; or 15 or more years of experience without an advanced degree.
  • Experience in medical device manufacturing, development, testing, or design; GMP, FDA, and ISO requirements; writing protocols, test plans, and test reports; design control regulation; and catheter and stent experience.
  • A strong foundation in mechanical and/or biomedical engineering principles, with demonstrated experience in medical device design, verification and validation, and sustaining engineering activities.
  • A clear understanding of how product performance, safety, and reliability affect patient outcomes, with consistent prioritization of risk mitigation and clinical effectiveness.
  • Working knowledge of FDA Quality System Regulations, ISO 13485, design controls, risk management (ISO 14971), and GMP requirements, with meticulous documentation and defensible data practices.
  • Proficiency in developing robust test strategies, applying statistical tools, interpreting complex datasets, and drawing technical conclusions to support regulatory submissions and engineering decisions.
  • Skill in conducting FMEAs, root cause investigations, and hazard analyses, and implementing effective corrective and preventive actions.
  • Ability to partner with R&D, Manufacturing, Quality, Regulatory, Clinical, and external stakeholders to foster alignment and shared accountability.
  • Ability to provide technical direction, mentor junior engineers and technicians, and present complex information to leadership and cross-functional teams.
  • Ability to manage multiple priorities in a fast-paced development environment and deliver high-quality work within timelines and project milestones.
  • Ability to communicate technical concepts clearly in written reports, protocols, presentations, and cross-functional discussions.
  • Ability to exercise sound engineering judgment, take thoughtful risks when appropriate, and own outcomes transparently and accountably.

Responsibilities

  • Lead the development and execution of science-based testing strategies, including drafting test plans such as experimental designs and statistical analyses, and detailed reports to ensure design robustness and regulatory compliance.
  • Conceptualize, develop, validate, and refine test methods for product design, verification and validation, and global regulatory submissions, using accurate, transparent, and defensible data practices.
  • Partner with New Product Development teams to support component qualification and create and maintain Product Development Process deliverables, including Design Specifications, FMEAs, and Traceability Matrices, aligned with quality system requirements and design control standards.
  • Document work according to GMPs, SOPs, and the company quality system, maintaining audit readiness and full traceability.
  • Provide technical leadership and direction while collaborating with senior management, engineers, technicians, and cross-functional stakeholders to achieve project milestones and commercialization.
  • Evaluate and influence designs for new products, product enhancements, components, assemblies, and tooling, balancing innovation with risk mitigation and manufacturability.
  • Conduct failure investigations, root cause analyses, and technical risk assessments to identify hazards and implement mitigations within Design and Process FMEAs.
  • Collaborate with R&D, Manufacturing, Regulatory, Quality, and Clinical teams to resolve technical issues, support sustaining engineering, and maintain product performance and safety in the field.
  • Identify opportunities for product improvement, process optimization, and cost efficiencies while balancing risk and innovation.
  • Mentor junior engineers and technicians.
  • Engage with physician partners and external stakeholders, when appropriate, to ensure product designs address clinical needs.
  • Perform additional responsibilities as assigned to support team objectives and organizational goals.

Desired Qualifications

  • Experience with medical device manufacturing, development, testing, or design; GMP, FDA, and ISO requirements; writing protocols, test plans, and test reports; design control regulation; and catheters and stents.
  • A bachelor's degree in Mechanical Engineering or Biomedical Engineering.

About the Company

Endologix

Medical devices for durable vascular repair

Endologix develops vascular medical devices to treat abdominal aortic aneurysms (AAA) and peripheral artery disease (PAD). It sells advanced graft systems used inside blood vessels to repair weakened arteries and improve blood flow. Its products, such as AFX, Ovation, and ALTO, are designed to fit and work with a patient's own artery anatomy to provide durable, stable repairs and preserve the natural bifurcation of the vessels. The company differentiates itself through a focus on preserving native vascular anatomy, offering personalized repair options, and pursuing ongoing clinical excellence and product refinement. Its goal is to help healthcare professionals deliver better outcomes for patients with vascular conditions by providing reliable, long-lasting devices that address unmet needs in vascular care.

Company size
501-1,000
Company stage
IPO
Headquarters
Santa Rosa, CA
Founded
1992

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