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.