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A medical devices company in Sungai Petani is seeking a hands-on R&D Executive to lead the development of innovative medical devices. The ideal candidate will possess a strong engineering background and relevant experience in product development, particularly in injection molding. Responsibilities include project leadership, prototyping, and ensuring compliance with regulatory standards. Competitive monthly salary is offered.
We are looking for a hands‑on, results‑oriented R&D Executive to drive the development of our next generation of medical devices. The ideal candidate will have a strong background in engineering and a proven track record of taking products from concept to market launch. This role is central to our innovation pipeline and requires deep technical expertise, especially in plastic injection molding and technical drawings.
Project Leadership: Lead and manage R&D projects for new medical devices, overseeing the entire product development lifecycle from initial concept, prototyping, and testing to design verification, validation, and transfer to manufacturing.
Design & Development: Create, review, and analyze 3D models and 2D technical drawings. Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
Injection Molding Expertise: Serve as the subject matter expert for plastic injection molding. This includes material selection (medical‑grade polymers), part design optimization, mold/tooling design input, and troubleshooting manufacturing processes.
Prototyping & Testing: Develop prototypes for testing, design test fixtures, and execute rigorous testing protocols to verify that designs meet functional and regulatory requirements.
Technical Documentation: Prepare and maintain comprehensive design history files (DHF) in compliance with medical device regulations (e.g., ISO 13485, FDA QSR).
Cross‑Functional Collaboration: Work closely with cross‑functional teams, including Product Management, Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure project goals and timelines are met.
Supplier Management: Liaise with external vendors, such as tooling manufacturers, molding partners, and material suppliers, to ensure quality and specification compliance.
Your application will include the following questions: