R&D Engineer

2 weeks ago

Santa Rosa, CA, United States Endologix Full time
Overview

Join Our Exciting Team as an 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 R&D Engineer will work with cross functional team members for new projects beginning with creation of the Project Charter to assure achievement of Endologix's goals and objectives.

Responsibilities

  • Assist in the design and development of new or enhanced stent grafts and delivery systems from pre-clinical development through product commercialization.
  • Assist in developing and ensuring execution of rigorous testing of projects by designing thorough test plans (i.e. experimental design, data evaluation, generation of scientific reports).
  • Excellent teamwork and organizational skills.
  • Collaborates with R&D, Manufacturing, Regulatory and Quality departments to coordinate focused efforts on investigations and resolves issues associated with product or other technical related issues.
  • Demonstrate the ability to provide technical procedure/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. Document all work according to GMP and SOPs.
  • Conducts testing to verify that the design meets the engineering specifications.
  • Assess failure modes and conduct technical risk analysis.
  • Document engineering work in compliance with the company's quality system.
  • Identifies hazards and mitigates risk associated with identified hazards in Design and Process FMEA.
  • May develop procedures and processes within broader protocols.
  • Conducts or manages research, analysis or processes within a larger R&D activity.
  • May develop and implement standards for operations and reporting.
  • Ensures completion of activities within compliance and on-time.
  • May identify and implements process level efficiencies.
  • May be responsible for operating within a budget.
  • May provide work instruction or supervision to team resources of professional and technical employees for initiatives and projects.
  • Perform other duties as assigned by supervisor.
Qualifications

Education:
  • Bachelor's degree in Mechanical Engineering, Bioengineering from a four-year college or university; or related major in Life Sciences preferred.
Experience:
  • 2-3 years in medical device manufacturing, development, testing, or designing, GMP, FDA, and ISO requirements and experience writing protocols, test plans, and test reports.


Compensation: $80K - $100K/Annual

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

Endologix, LLC. 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.

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