Engineer I, Research and Development

Jenavalve Technology Inc; Irvine (CA); On-site; USD 75,000 - 110,000; Full time

Job summary

Jenavalve Technology Inc. in Irvine, CA seeks an Engineer, Research and Development to contribute to subsystems and components for transcatheter heart valves and delivery systems.

Responsibilities include designing and documenting components, procuring parts, developing assembly procedures, performing feasibility tests, and partnering with Quality and Manufacturing to ensure design verification and production transfers. Supervising technicians is also part of the role.

Qualifications

• BS in Mechanical or Biomedical Engineering required.
• 0–2+ years experience; levels I–III DOE.
• Experience with medical device product development and Quality System requirements.

Responsibilities

• Develop components or subsystems for transcatheter heart valves and delivery systems.
• Design and document components and subsystems; procure components.
• Develop assembly procedures and conduct feasibility testing.
• Partner with Quality for risk analysis and design verification.
• Partner with Manufacturing to transfer product to external manufacturers.
• Supervise technicians.

Skills

Team collaboration

Verbal and written communication

Documentation

Hands-on engineering

Attention to detail

Education

Bachelor of Science in Mechanical or Biomedical Engineering

Job description

Job Title: Engineer, Research and DevelopmentEngineer I, Research and DevelopmentEngineer II Research and DevelopmentEngineer III Research and DevelopmentSupervisor/Manager Title: Principal Engineer, Research and DevelopmentJob Description Summary: Responsible for the development of subsystems and components for transcatheter heart valves and delivery systemsJob ResponsibilitiesDevelop 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 skillsMust 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.