Identify business unmet need on polymeric material cross coronary and structure heart business and perform technology scouting and evaluation on new material and process technology to solve problem and build platform technology for future product development. Leads research/development projects in multi-functional project teams (as assigned). Design and development of new and modified coronary & structural heart device for medical applications in a regulated environment. Activities will include technology scouting, build material strategy, methods/process development, prototype building/testing, design modeling, tooling design/fabrication, equipment design/fabrication, qualification, validation, and documentation.
Technical resource to all departments and represents R&D on project teams.
Communication across business units and key stakeholders to identify unmet material need.
Design and implementation of new coronary & structural heart device based on requirements specifications.
Technology scouting and identify opportunities for feasibility studies to prove concept.
Performs feasibility test and Specifies tests for product testing based on design specifications and applicable guidelines (industrial and government guidelines and/or standards).
Performs data analysis (statistical and practical) and develops appropriate action plans based upon such analysis.
Develops tooling and test equipment designs for product assembly and testing. Examples of pertinent duties include creating CAD drawings, equipment modeling, specifications development.
Prepares plans and schedules for own work and others as required.
Communicates progress and decisions to associates and functional manager.
Project leader for research projects (as assigned). Duties include project schedule maintenance, organize and facilitate team meetings, project documentation, and coordination of project team activities.
Participates in technical reviews.
Follows company policies and procedures.
Identifies opportunities productivity and quality improvements.
Performs other duties as assigned.
IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME
BS in Material science, Polymer engineering or Biomedical Engineering, or BS in related field with appropriate engineering course work. Master in biomedical engineering preferred.
Years of Experience
Min. 5 years of medical device engineering work , preferred 3-5 years in prosthetic heart valve product development design and testing.
Specific knowledge of Domestic and International standards for cardiovascular diseases and devices.
Experience with delivery system material development and material selection
Curious about new technologies, interest in phase 0 projects and development of new concepts and problem solving.
Specialized Knowledge or Skills
(Needs to be objective, relevant, and non-comparative)
Knowledge of United States and International regulatory requirements (medical device, general), GMPs and industry standards/guidelines.
Deep understanding of polymeric material property, characterization and manufacturing process(extrusion, injection, additives, etc. ).
Understanding of implant-tissue interaction and evaluation
Computer Skills : CAD; Microsoft Word, Excel, Project, and PowerPoint; LabVIEW; Matlab
Excellent verbal and written communication skills
Project management and planning
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile.
The employee is also required to interact with a computer, and communicate with peers and co-workers.
Other examples: Able to lift 25 pounds, Able to view items through microscope, Extended periods of time doing computer-based work
Specific vision abilities required sometimes include close vision, color vision, and ability to adjust focus.
Able to travel ~25%