R&D Engineer 2

Position Summary

The candidate will participate in cross functional reviews of the Technical Files to ensure all test requirements are being planned and executed in a timely manner. 
•    Plan and coordinate activities of technical resources assigned to updating Tech Files and Design Dossiers in preparation for new regulations. 
•    Coordinate overall planning and resource allocation and activities to meet target dates as defined by the BU regulatory lead
•    Generate test protocols, analyze test data, and generate written reports.
•    Contribute to design documentation including input for the DHF and technical design reviews.
•    For in house manufactured and purchased components, plan and lead the verification and validation activities for new/replacement and existing products and components.
•    Individually deliver or guide technical resources in the development/improvement of products and processes, optimize by utilizing tools such as DOE, accomplish their evaluation through verification and validation, and assist in their implementation with appropriate controls and metrics.
•    Meet project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.
•    Interface with suppliers to obtain information required to update Tech Files and DHF documentation. Interface with purchasing and marketing to develop supplier agreements for components and/or new products.
•    Direct the efforts of technicians and lab personnel in the development of test fixtures, equipment, test procedures and documentation.
•    Lead and participate in design and technical phase reviews.
•    Ensure projects are developed and documented compliant with the Quality System.
•    Perform any other relevant and related responsibilities that may be assigned from time to time as required by superior.
 

Principal Responsibilities

Education / Experience Requirements

•    Degree in Industrial/Mechanical Engineering or equivalent.
•    Knowledge of PVC and/or Silicone Processing and process development will be an added advantage.
•    2-3 years previous experience in related field (e.g. medical device R&D, manufacturing and assembly, disposables manufacturing processes, plastics, silicone)

Specialized Skills / Other Requirements

•    Must be able to communicate (written and verbal) in English and Malay language.
•    Strong project management, documentation and problem-solving skills.
•    Good knowledge in Engineering Testing, Jig and Fixture, etc.
•    Good interpersonal skills that include working well in a team environment and the ability to lead others.
•    Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
•    Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
•    Knowledge of Solidworks or equivalent CAD software is a Plus.
•    Computer Literate (MS. Excel, Word, PowerPoint, etc).