Sr. R&D Engineer

Overview

Join Our Exciting Team as a Sr. R&D Engineer!

Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease.  We have a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence. 

Job Summary:

The Sr. R&D Engineer is responsible for providing technical know-how in the development of enhanced and new stent graft and catheter-based delivery systems to assure achievement of Endologix’s goals and objectives.

Responsibilities

• Ownership in the development and execution of rigorous testing approaches on projects by drafting thorough test plans (i.e. experimental design, statistical analyses) and report (i.e. data analysis, interpretation) that meet engineering objectives.
• Conceptualize, develop and validate test methods in support of design and development efforts as well as regulatory submissions.
• Collaborate with NPD teams to support component qualification and the development of PDP documents (i.e. Design Specifications, FMEA's, Design Trace Matrix, etc.).
• Document all work according to GMPs and SOPs in compliance with the company's quality system.
• Provide technical direction and interact professionally and effectively with senior management, peers, team members, supervisors, outside customers, and other teams/departments on an ongoing basis to ensure product development success.
• Work with engineers at all levels to evaluate designs for new products, product revisions, components, assemblies or tools.
• Indirectly mentor/supervise technicians or junior professionals.
• Collaborate with R&D, Manufacturing, Regulatory, and Quality departments to coordinate focused efforts on investigations that resolve issues associated with products or other technical matters.
• Assess failure modes and conduct technical risk analyses.
• Identify hazards and mitigate risks associated with identified hazards in Design and Process FMEA.

Qualifications

Qualifications:

• Excellent teamwork and organizational skills.
• Excellent written and verbal communication skills.
• Focused experience sustaining currently marketed products with emphasis on failure mode root cause analysis and novel problem solving.
• Solid academic foundation in the engineering and biological disciplines (i.e. cardiovascular anatomy and physiology, chemistry, physics, solid and fluid mechanics).
• Working knowledge of polymer chemistry.
• Demonstrated experience with thin film PTFE materials.
• Aptitude in conducting novel basic science research to inform product evaluation and design.
• Strong understanding of quality and regulatory systems in a Class III regulated environment.

Education:

• Bachelor's degree in Engineering discipline (mechanical/biomedical preferred) or equivalent experience.

Experience:

• 5 years of experience with a Bachelor's degree, 3 years 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.

Join us, and bring your point of view, talents, and contributions so we can all grow together. 

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.