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.
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.
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.
JenaValve Technology Irvine, California, USA Office
4 Cromwell, Suite 100, Irvine, CA, United States, 92618
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