Job Description

Client background: US Medical Manufacturing company Position title: R&D Manager Headcount: 1 Tenure: Permanent Location: Kulim, Kedah Responsibilities: . Conducts research or development projects associated with the design and design modifications of medical devices, components, models, or mechanisms. Ensures staff prepares or coordinates formal documentation of the product Designs, Risk Analysis, Product Specifications, User Needs, etc. according to established Design Control Procedures, and initiates formal reviews to get approved per procedures. Responsible for remediation and updates of Design History Files, Technical Files or other product registration efforts as required. Responsible to ensure Design History Files and Technical Files are current to current regulatory requirements. Ensures staff is trained to all current procedures and regulatory requirements required for successful performance of their positions. Develops, maintains and publishes product Development Plans for assigned projects with critical milestones and timelines. Coordinates the product design and development process with appropriate support departments such as engineering, quality, regulatory, documentation, global procurement, and manufacturing. Assigns project leaders for assigned projects and responsible to follow up on all aspects of projects, including reviews with support groups and outside resources where applicable. Ensures staff prepares or follows up on preparation of design drawings, specifications, estimates of costs, system updates, etc. Discusses and consults with sales, clinical, etc. on product requirements and specifications where design or manufacturing problems are involved. Works with manufacturing in the justification and the selection of the manufacturing process and assigns projects and establishes priorities to ensure datelines and goals are achieved. Coordinates the reporting on project status for all responsible projects and directs reports in formal periodic project review meetings, which include cost reduction, progress, capital spending and expense status. Reports via electronic systems as appropriate. Enhances growth and development through participation in education programs, professional development, industry conferences, current literature, training meetings and workshops. Mentor for junior level employees. Participates actively in continuous quality improvement activities through compliance with safety standards. Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives. Maintains compliance with principles of accepted employee conduct as identified in the company policies, procedures, and core values. Manage Development Engineers and Project Teams effectively. Demonstrate creativity and ingenuity in applying engineering principles and practices. Draw solutions form a wider range of experience. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists interprets a variety of instructions furnished in written, oral, diagram, or schedule form. Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department. Analyze complex, technical, and administrative problems and adopt an effective course of action. Conduct comprehensive studies and preparation of reports including recommendations. Develop project and departmental budgets and schedules and provide regular reporting. Conduct Personnel Evaluations for direct reports, recommend employee actions. Performs other related duties as assigned or requested. Qualifications & Experiences: . Possession of MS or BS degree in engineering or closely related field. Possession of specific degree may be substituted by equivalent work experience in the design and/or modification of plastic components for the medical industry. . At least 5-7 years of progressive responsibility in leadership role and professional engineering experience in Medical Device Development, Plastic, Silicone part design experience is mandatory. CADD (design/drafting) program, to include SolidWorks Experience is added advantage. . Proficient in the Microsoft Office Suite, (Project, Word, Excel, and PowerPoint). Plastic / LSR Injection molding, plastic extrusion and molded part assembly process and methods experience. Basic Lab principles and operation. U.S. FDA GMP, International Regulations and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices. ISO and ASTM testing methods for medical devices and general plastic components.

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