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.
Skills Required
- Bachelor of Science degree in Engineering or Technical discipline
- Minimum of 6+ years' experience in R&D or product development of medical devices, pharmaceutical or life science products
- Familiarity with 21CFR820 and ISO 13485 requirements
- Knowledge of product development process and applicable Quality System requirements in medical device industry
- Hands-on experience in product development within an R&D lab environment
- Experience developing product specifications and writing design verification and validation protocols
- Strong SolidWorks/CAD skills
- Knowledge of statistical analysis and applications
- Project management skills
- Demonstrated ability to communicate technical information in written and oral form
- Ability to work effectively and collaborate within cross-functional teams
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.
