Principal Responsibilities
• Plan, staff , implement , control and evaluate related projects.
• Accountable for project within the organization to meet the business objectives.
• Ensure quality and accuracy of integrated project plans encompassing all cross-functional activities.
• Develop comprehensive project plans, including business case, scope, objectives, deliverables, timelines, resource allocation, and budget.
• Perform periodic reviews of progress against plans. Ensure plans are executed appropriately within the department. Be accountable for timely delivery of all product development deliverables as specified in the plans.
• Manage project risks, identify potential issues, and develop mitigation plan & strategies to keep projects on track and timely communication to all stake holders.
• Coordinate and communicate effectively with cross-functional teams (R&D, Quality, Engineering, Ops, Supply Chain, Regulatory Affairs & etc) to ensure project alignment and successful execution.
• Create and stimulates an open environment conductive to the creativity, innovation and “out of the box” approaches.
• Develop and coordinate the execution of protocols for the validation of new or modified devices or components including validations of design, manufacturing, assembly packaging and sterilization where applicable with development engineers and appropriate support group departments such as Quality Assurance, Material Management and Operations.
• Work with Manufacturing in the justification and the selection of the manufacturing process and assign projects and establish priorities to ensure deadlines and goals are achieved.
• Interface with process engineering and quality engineering to coordinate changes in process, tooling, equipment and material identified to positively impact the manufacturing process while staying within the regulatory requirements and Product Design Control Procedures.
• Ensure all project activities adhere to medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820), Occupational Safety and Health Act 1994 and internal quality system procedures.
• Oversee Continuous Improvement projects CAPEX spending are as per planned in project planning stage and ensure PEA is raised at stipulated time to meet the spending plan.
• Lead and manage Global initiatives, Site Operations and Manufacturing system projects when required.
• Perform any other duties that may be assigned from time to time by the Management.
Education / Experience Requirements
• Degree / Diploma in Engineering related or Material Science or other relevant field.
• Minimum 3 years relevant working experience in manufacturing environment.
• Project management and people management experience required, ideally in the medical device industry with a proven track record of delivering products to market.
Specialized Skills / Other Requirements
• Strong interpersonal and communication skill. Must be able to communicate fluently (written and verbal) in English and Malay Language.
• Strong organizational leadership, interpersonal and influencing skills.
• Strong technical, management judgment, and team orientation.
• Strong skills in project planning and management.
• Lean six sigma and automation experience.
• Proven working experience in project management in medical industry.
• Able to work independently with strong leadership ability.
Project Engineer • Kulim, 02, MY
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