R&D Engineer
Teleflex
- Kamunting, Perak
- Permanent
- Full-time
2. Serve as design control lead for new product development projects when required.
3. Coordinates cross-functionally with marketing, clinical, sales, regulatory, operations (Internal/External) and shared services teams to define and document user needs, design inputs and outputs, design transfer and commercialization deliverables.
4. Coordinates the development of concepts, prototypes, and corresponding test methods for rapid development cycles.
5. Accountable/responsible for creation of project and product DHF/DMR documentation including but not limited to Project Charters or Plans, CAPA's & R&D Investigations, Business Documents, Design Control and D&D Plans.
6. Develops and/or coordinates the V&V plans and activities for new and existing products.
7. Works with the team to problem solve complex technical issues that clear obstacles to ensure successful project delivery.
8. Works across R&D development teams for SMEs and additional resource support by project/phase.
9. Creates partnerships across global Teleflex, engineering, and project team networks.
10. Works with Global Procurement, Operations, and external vendors to ensure development of a robust high value product supply chain and to identify opportunities to improve.
11. Develops assembly methods and procedures; creates engineering drawings and specifications.
12. Develops and maintains project plans with detailed schedules and critical milestones, risks, resource loading and budgets. Maintains timely project plan data in appropriate data systems and reporting dashboards.
13. Develops and coordinates the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable.
14. Demonstrates professional responsibility by collaborating with other personnel to achieve department goals while fostering an enjoyable environment.
15. Resolves complex process/product development and manufacturing issues; independently takes lead of working cross functional teams.
16. Prepares formal documentation of the product designs, risk analysis, product specifications, etc. according to established product development procedures.
17. Initiates formal reviews to get approved per said procedures.
18. Investigates and resolves technical production problems involving product performance.
19. Performs other related duties as assigned or requested.Education / Experience RequirementsQualification :
A bachelor's degree is required; degreed technical field or master's degree is preferred.Experience :
- 5 years of professional work experience in the project management, engineering for the development of medical devices.
- Project Management experience preferred.
- Proficiency in the Microsoft Office Suite, (Project, Word, Excel, and Access) is required.
- Injection molding, plastic extrusion and plastic part assembly process and methods
- U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices
- Design Control experience: technical mindset to develop skillset required.