Staff Engineer I, THV Research and Development-THV

**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.