Design and develop components and subsystems for transcatheter heart valves and delivery systems. Create and review drawings/specifications, develop test methods, conduct analyses and verification testing, partner with Quality and Manufacturing, perform vendor evaluation and failure analysis, and supervise R&D technicians.
Job Title: Staff Engineer, THV Research and Development
- Staff Engineer I, Research and Development
- Staff Engineer II, Research and Development
- Staff Engineer III, Research and Development
Supervisor/Manager Title: Director, Research and Development
Job Description Summary: Responsible for the development of novel subsystems and components for transcatheter heart valves and/or delivery systems.
Job Responsibilities:
- Conceive, design, and develop components and subsystems of moderate/high complexity for transcatheter heart valves and/or delivery systems in accordance with quality system requirements and with minimal supervision.
- Create, review and/or approve component and subsystem drawings/specifications and documentation.
- Identify/evaluate vendors, procure components and develop component specifications.
- Develop test methods, conduct testing, and interpret data.
- Conduct engineering analyses and feasibility testing of components and subsystems to ensure proper fit and function.
- Conduct competitive product evaluation and product failure analyses.
- Partner with Quality to conduct risk analyses and develop/execute design verification activities.
- Partner with Manufacturing to develop manufacturing processes, tooling/fixtures, and transfer product/processes to manufacturing.
- Supervise R&D Technicians.
Required Education and Experience:
- A Bachelor of Science degree in Engineering or Technical discipline with related work experience.
- Minimum of 6+ years’ experience in R&D or product development of medical devices, pharmaceutical or life science product technology. Level I, II, III DOE
- Familiarity with 21CFR820 and ISO 13485 requirements.
- Knowledge of the product development process and applicable Quality System requirements in the medical device industry.
- Demonstration of ability to work effectively and collaborate within cross-functional teams.
- Demonstration of ability to effectively communicate (in oral presentation and written documentation) test protocols, reports, and technical summaries to technical and non-technical personnel.
- Hands-on experience in product development within an R&D lab environment.
Skills and Abilities Required for This Job:
- Ability to work independently and in collaboration within cross-functional teams.
- Ability to manage multiple tasks in a timely manner with high attention to detail.
- Ability to build strong relationships at all levels of the organization, cross-functionally and with key external personnel.
- Demonstrated strength in problem analysis, judgment, decision making and critical thinking
- Strong written and verbal communication.
- Experience in developing product specifications based on user needs and writing design verification and validation protocols.
- Strong Solidworks/CAD skills.
- Project management skills.
- Knowledge of statistical analysis and applications.
JenaValve Technology Irvine, California, USA Office
4 Cromwell, Suite 100, Irvine, CA, United States, 92618
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