Description This position will be responsible for leading the concept generation, design, development, prototyping and testing, validation, FDA and other regulatory body approval, and launch of innovative catheter-based products (coronary and peripheral), with concept to launch responsibility. Responsibilities also include obtaining Voice of Customer and Design Inputs, creating program plans and Design History Files, creating and leading cross-functional teams, developing and validating test methods, Design Verification and Design Validation testing, and validation and transfer of processes to manufacturing. May include management of personnel and budgets. Serve as the technical expert in his/her area(s) of engineering inside and outside the company.
Position Requirements
1. Lead the concept generation, design, development, prototyping and testing, validation, FDA and other regulatory body approval and launch of innovative catheter-based products (coronary and peripheral), with concept to launch responsibility
2. Obtain Voice of Customer and Design Inputs, create program plans and Design History Files, create and lead cross-functional teams, develop and validate test methods, Design Verification and Design Validation testing, and validation and transfer of processes to manufacturing
3. Likely to include management of personnel and budgets
4. Assign / delegate engineering related duties or projects to lower level and/or outside engineers, designers, and technicians. Serve as mentor to entry level engineers
5. Serve as the technical expert in his/her area(s) of engineering inside and outside the company
6. Attend meetings, and prepare monthly reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders
7. Ensure compliance to Terumo’s quality policy
8. Associate is responsible to follow all requirements of applicable national and international regulations
9. 10 years minimum experience in medical device R&D
10. Experience in collecting and analyzing Voice of Customer (VOC), interaction with physicians and concept development
11. Experience in leading cross-functional teams from concept to launch of new medical devices
12. Experience in design, development, testing, FDA approval and launch of catheter-based products
13. Track record of innovation and patents
14. Experience in direct people management
15. Experience in 510(k) and/or IDE/PMA submissions
16. Expertise in balloon blowing processes for development of balloon catheters would be a plus
17. Expertise in Computer Aided Design, especially Solidworks, would be a plus
18. Excellent analytical and problem solving skills
19. Thorough knowledge of statistical techniques / methods
20. Excellent communication skills both verbal and written
21. Performs other job related duties assigned
Educational Requirements
1.BS in Mechanical Engineering or related field, Advanced Degree (MS / PhD) preferred
About the Organization Terumo Medical Corporation is firmly committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of age, race, color, gender, national origin, religion, disability, protected veteran status and other protected classifications.