Sr. R&D Engineer

Endologix Irvine , CA 92606

Posted 3 months ago

Overview

Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

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

  • Responsible for providing the technical know-how 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

  • Work with engineers, machinist, and QA to create designs for new products, product revisions, components, assemblies or tools

  • 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

  • May indirectly supervise technicians and lead cross-functional development teams.

  • Identifies hazards and mitigates risk associated with identified hazards in Design and Process FMEA.

  • Uses expertise to improve operational efficiencies and meet compliance requirements

  • Complies and analyzes data, identifies causes, draws conclusions, generates reports

  • Manages processes and ensures that activity goals are achieved

  • May act as team leader and/or mentor junior professionals

  • May draft protocols for approval

  • Responsible for maintaining compliance, consistency of practices and work quality

  • May be responsible for operating within a budget

  • Typically manage processes and may supervise or provide instruction to professional and technical employees on projects and initiatives

  • 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:

  • Five years with a Bachelor's degree, Three years with a Master's degree 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.

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status or any other characteristic protected by applicable federal, state, or local law.

If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800


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Sr. R&D Engineer

Endologix