TE Connectivity India Pvt Ltd
TE Connectivity’s R&D / Product Development Engineering Teams conceive original ideas for new products, introduce them into practice.
They are responsible for product development, and qualification from market definition through production and release; assist in the qualification of suppliers for new products to ensure suppliers deliver quality parts, materials, and services for new or improved manufacturing processes;
conduct feasibility studies, testing on new and modified designs; direct and support detailed design, testing, prototype fabrication and manufacturing ramp.
The R&D / Product Development Engineering Teams provide all required product documentation including, but not limited to, Solid Model, 2D / 3D production drawings, product specifications, and testing requirements.
They create and modify detailed drawings and drafting or conceptual models from layouts, rough sketches or notes and contribute to design modifications to facilitate manufacturing operation or quality of product.
Typical fields of expertise include : materials, mechanics and systems, electrical, optics, chemistry, software, automation systems, packaging, testing and measurement, and manufacturing of electrical, mechanical and electronic components, products, and their integration into systems.
Responsibilities & Qualifications
Work on all product design efforts on medical device projects from concept generation through to design verification. The products include devices for neurovascular, structural heart, coronary and peripheral vascular disease, electrophysiology, endoscopy, and general surgery.
Lead and be an integral part of the team tasked with the development process from concept generation through to design verification.
Assist in the development of intellectual property generated by development activities.
Ensure the application of new and existing technologies to provide the optimum delivery system design.
Participate in trials with physicians to provide clinically relevant feedback on product designs.
Provide technical feedback during frequent technical contact with customers to optimize product design.
Support the maintenance of product files and other relevant documentation to comply with quality standards.
Compile project plans and lead team to develop devices in accordance with planned activities, budget and timelines.
All other duties as required
Qualifications / Essential Experience :
Engineering degree with 8+ year’s industry experience in a medical product development environment with a proven track record of leading teams in device development.
Proven experience of work with catheter technology, catheter design and testing and catheter manufacturing a distinct advantage.
Experience of coordinating and leading Design Reviews and the compilation of associated documentation.
Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements.
Proven experience of minimally invasive Medical Device design, development and manufacturing.
Leading the team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities.
Proven experience in leading teams performing FMEA’s, verifications and validations for medical devices products and processes.
Knowledge and experience with Medical Device sterilization processes, specifically gamma and EtO sterilization.
Experience with engineering tools such as DOE, SPC, and using Minitab
3D modeling experience.
Working knowledge of biocompatible metal and / or polymer materials.
Demonstrate a working knowledge of the required activities and deliverables from each of the development phases.
Availability to participate in limited travelling to meet with customers to conduct scheduled reviews.
It is essential that the candidate will be highly innovative, motivated and organized and have excellent planning and communication skills
Values : Integrity, Accountability,Teamwork, Innovation