A client in Santa Rosa, CA has a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Their existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease.
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 the company'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
- 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:
Experience:
- 5 years of experience with a Bachelor's degree, 3 years with a Master's 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.