Lead cross functional development teams for sustaining engineering and new product development activities in support of carotid and peripheral vascular products. Interact with physicians and functional team members to understand customer needs and translate these needs into product specifications.
· Provide Project and Technical Leadership for cross-functional team(s) tasked with Designing and Developing devices and
procedures to address unmet clinical needs.
· Work with Marketing, Clinical, Medical Director, and physician advisors to understand customer needs.
· Design, prototype and develop novel design solutions to improve performance and ease of use of clinical procedures.
· Develop, author and execute test methods for perform robust design evaluations, ensuring product designs meet customer
needs. This includes bench testing, physical and/or computer model development, and ex vivo and/or in vivo testing as
· Leverage external resources (e.g., Consultants, Contract Manufacturers) to supplement R&D, process development and
future manufacturing needs as appropriate.
· Maintain Design Control activities for product development projects, including (but not limited to):
o Collect design inputs via input from advisors and initial design evaluations
o Develop product specifications
o Establish Design Verification and Validation strategies
o Lead Risk Assessment/Risk Management
o Establish and managing project timelines and budgets
o Lead Design Reviews
· Support Company functions as needed, including R&D, Operations, Quality, Clinical and Regulatory.
· Support the development and upkeep of the Company’s quality system in conjunction with the Company’s Quality
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
· BS or greater in Engineering/Technical field.
· Minimum 8 years of experience in medical device R&D with a focus on design, evaluation and validation of catheters, guidewires, and delivery systems. Extensive knowledge and experience with Design Control.
· Established track record leading cross functional project teams within ISO-compliant Design Control Procedures, from Concept through Market Release.
· Hands-on design and prototyping and skills.
· Strong verbal and written communication skills, including day-to-day interaction with cross-functional team members and frequent interface with customers/physician advisors.