Engineer I, Research and Development

Posted 3 Days Ago
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92618, Irvine, CA, USA
In-Office
84K-84K Annually
Entry level
Healthtech
The Role
Develops and documents mechanical or biomedical components and subsystems for transcatheter heart valves and delivery systems. Responsibilities include component procurement, assembly procedure development, engineering analysis, feasibility testing, design verification, risk analysis, manufacturing process development, product transfer, and technician supervision. The role requires collaboration with Quality, Manufacturing, and cross-functional teams while following medical device quality system requirements.
Summary Generated by Built In

Job Title: Engineer, Research and Development

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

Supervisor/Manager Title: Principal Engineer, 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.
  • 0-2+ years experience. 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
  • 0-2+ years of engineering experience
  • Knowledge of product development processes and applicable medical device quality system requirements
  • Ability to collaborate effectively within cross-functional teams
  • Ability to communicate results and conclusions verbally and in writing to technical and non-technical personnel
  • 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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