Senior Engineer I, Research and Development

Posted Yesterday
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92618, Irvine, CA, USA
In-Office
101K-101K Annually
Senior level
Healthtech
The Role
Develops and documents components and subsystems for transcatheter heart valves and delivery systems. Performs engineering analysis, feasibility testing, risk analysis, and design verification. Collaborates with Quality and Manufacturing on procedures, processes, and product transfer to external manufacturers. Procures components, develops assembly procedures, and supervises technicians while ensuring compliance with medical device quality systems.
Summary Generated by Built In

Job Title: Senior Engineer, Research and Development

  • Senior Engineer I, Research and Development
  • Senior Engineer II, Research and Development
  • Senior Engineer III, Research and Development

Job Description Summary: Responsible for the development of subsystems and components for transcatheter heart valves and delivery systems

Job Responsibilities:

  • Develop components or subsystems for transcatheter heart valves and delivery systems in accordance with quality system requirements.
  • Design and document components and subsystems.
  • Procure components.
  • Develop assembly procedures.
  • Conduct engineering analysis and feasibility testing of components of subsystems to ensure proper fit and function.
  • Partner with Quality to conduct risk analysis and develop and execute design verification activities.
  • Partner with Manufacturing to develop manufacturing procedures and processes and transfer the product to external manufacturing houses.
  • Supervise Technicians.
Qualifications

Required Education and Experience:

  • A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.
  • Minimum of 3-5+ years of experience in Research & Development is required. Level I, II, III DOE.
  • Knowledge of the product development process and applicable Quality System requirements in the medical device industry is required.
  • Must be able to work effectively and collaborate within cross functional teams.
  • Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
  • Must have strong documentation skills
  • Must take initiative and have the ability to conduct hands-on work.
  • Must possess the ability to handle multiple tasks with high attention to detail.

Skills and Abilities Required for This Job:

  • Must be able to work effectively and collaborate within cross functional teams.
  • Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
  • Must have strong documentation skills.
  • Must take initiative and have the ability to conduct hands-on work.
  • Must possess the ability to handle tasks with high attention to detail.

Skills Required

  • Bachelor of Science degree in Mechanical Engineering, Biomedical Engineering, or an equivalent engineering discipline
  • 3-5+ years of Research and Development experience
  • Knowledge of product development processes and applicable medical device quality system requirements
  • Ability to collaborate effectively within cross-functional teams
  • Ability to communicate technical results and conclusions verbally and in writing
  • Strong documentation skills
  • Initiative and ability to perform hands-on work
  • Ability to manage multiple tasks with high attention to detail
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The Company
HQ: Irvine, CA
136 Employees
Year Founded: 2013

What We Do

JenaValve Technology, Inc., with locations in Irvine, Calif., Leeds, U.K. and Munich, Germany, develops and manufactures transcatheter aortic valve replacement (TAVR) systems to treat patients suffering from aortic valve disease. The Company is in clinical development of its next-generation transfemoral TAVR system in both the U.S. and CE mark countries for treating patients with aortic stenosis and/or aortic regurgitation. In addition to Bain Capital Life Sciences, JenaValve is backed by European and Asian investors, including Andera Partners (formerly Edmond de Rothschild Investment Partners), Gimv (Euronext: GIMB), Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners. Additional information is available at www.jenavalve.com.

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