R and D Engineer - Principal

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Help bring the next generation of life-changing medical technology to patients worldwide.

This Principal R&D Engineer will contribute to the development and improvement of new transcatheter heart valve replacement products that meet application, business, and customer requirements. This role will also shape and execute scientific and engineering strategies in the face of loose requirements, to drive expansion of the transcatheter heart valve market. Conduct design verification and validation testing per approved protocols and document in accordance with applicable development regulatory requirements. Collaborate with design colleagues to ensure designs are capable of meeting performance targets. Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies. Support multiple projects within the Development group.

A Day in the Life:
•Design, develop, and validate new advanced test methods, measurement techniques, and fixtures, particularly those related to fluid dynamics.
•Contribute to the development of design solutions that address broad development problems involving class III implantable devices and accessories.
•Direct the activities of technicians and engineers to ensure project milestones are completed correctly and on schedule.
•Develop verification and validation testing strategies and perform analysis to evaluate designs for short- and long-term performance and reliability.
•Work from basic clinical need to device concept to prototype.
•Interface with physicians and distil their needs into product requirements and concepts.
•May work with or lead a small team, and develop a test strategy/development path to achieve project goals; alternately may work largely independently to develop concepts, prototypes and/or new test methods. 
•Will apply knowledge of materials and processes to come up with working designs.
•May be required to progress a project from concept phase into commercialization phase and play a key role on the product / process / engineering / leadership fronts.
•Will need to interface effectively with Core and extended team members and other staff, across multiple geographic locations, to achieve goals.
•Work with development teams to translate customer and project requirements into performance criteria, novel approaches to data generation/analytics, and selection criteria to determine the optimum design approaches.
•Prepare detailed design specifications that define performance and interface requirements for components.
•Generate and document invention disclosures to secure intellectual property on therapies, procedures, and associated devices.
•Prepare and present technical information in a clear and effective manner to management, customers, and cross-functional team members, using clear and effective communications (oral, visual, written), demonstrations, and prototypes.
•Review and approve document change requests for design, materials, and process documentation. Create new documents for performance, design, and process specifications and test protocols and reports.

Must Have: Minimum Qualifications
•B.S. in a relevant engineering field, preferably Mechanical Engineering, Biomedical Engineering, or Aerospace Engineering
•Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience 

Nice to Have
•M.S. or Ph.D. in a relevant engineering field.
•Strong understanding of Design Controls and the Product Development Process.
•Experience with new product development or indication/geographic expansion, including regulatory submissions. 
•Ability to manage and drive projects independently. 
•Experience with requirements flow down. 
•Strong written and verbal communication skills. Fluent in English.
•Previous Heart Valve design and testing experience.
•Experience in the design and application of minimally invasive implantable devices.
•Hands on experience with laboratory testing equipment and methods, particularly fluid flows.
•Knowledge and experience in engineering mechanics, mechanical design, and structure and properties of materials.
•Knowledge of cardiovascular anatomy and physiology.