R&D Engineer
Teleflex
- Kamunting, Perak
- Permanent
- Full-time
2. Responsible for Test Method Development & Test Method Validation.
3. Responsible for Solidworks drafting for all the AEM products.
4. Develop, execute & document comprehensive test plans and strategies, and develop & build test cases based on the product requirements and usability.
5. Gathers data on current products and involve in improvement of product related documents to support production, engineering, and regulatory requests.
6. Lead multiple projects and make sure they are completed in a timely manner.
7. Understand and assist other team members in updating and maintaining risk documentation to conform to current standards.
8. Serve as a participant in integration core teams as the R&D representative and/or technical lead. Collaborate with the integration teams (Engineering, Quality, Regulatory) to understand technical targets and design control systems
9. Supports sustaining engineering efforts for the Manufacturing plants as applicable. Teleflex is a Global organization with manufacturing facilities in the US, Mexico, Czech Republic, Malaysia, India and Germany. Ability to travel in international locations in mandatory.
10. Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.
11. Implementation of new non-hazardous material into manufacturing post MDR certification (Design/ Manufacturing Transfer).
12. And any other assignment / task as deemed fit.Education / Experience RequirementsQualification :
Must have an undergraduate degree in a related engineering/material science field, graduate or advanced degrees strongly preferred.Experience :
- 2 years of medical device or other related design experience.
- Experience in SolidWorks CADD (design/drafting) program.
- Microsoft Office Suite, (Project, Word, Excel and Access).
- Background in Material Science preferred. Injection molding, plastic extrusion and plastic part assembly process and methods preferred.
- U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices preferred.
- ISO and ASTM testing methods for medical devices and general plastic components preferred.
- Principles and practices of professional engineering.
- Regulations pertaining to medical device design and design modifications preferred.
- Demonstrate creativity and ingenuity in applying engineering principles and practices.
- Draw solutions form a wider range of experience.
- Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department.
- Conduct comprehensive studies and preparation of reports including recommendations.
- Prepare clear and concise statements and reports.
- Establish and maintain cooperative relations with those contracted in the workplace.
- Speak and write English fluently.