Save Job Back to Search Job Description Summary Similar JobsCompetitive SalaryExpanding CompanyAbout Our ClientThis opportunity is with a large organization that is a leader in the life science industry. With a strong global presence, this company is renowned for their exceptional quality products and services. They have a diverse and inclusive workforce that is committed to driving growth and innovation.Job DescriptionLead and manage the engineering team, providing guidance and mentoring to team members, ensuring adherence to medical device industry standards.Oversee engineering activities including design, development, and implementation of products, production tools, jigs, and fixtures.Ensure all engineering outputs comply with applicable standards such as ISO 13485, FDA 21 CFR Part 820, and internal quality systems.Set up and manage the tooling department, including design & development, fabrication, maintenance and optimisation of tools, fixtures, and equipment to support manufacturing operations.Lead the New Product Introduction (NPI) transfer process from global sites, ensuring smooth integration into local operations while meeting project timelines, quality standards, and regulatory requirements.Collaborate closely with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and Global Engineering to support new and existing product development.Review and approve engineering drawings, documentation, and technical specifications to meet internal and external requirements.Conduct engineering risk assessments and develop effective mitigation strategies in line with regulatory expectations.Develop and manage engineering budgets, resource planning, and timelines to optimize project efficiency and ensure timely delivery of high-quality products.Drive continuous improvement initiatives to enhance product quality, reduce costs, and improve efficiency across engineering, tooling, and manufacturing operations.The Successful ApplicantA successful Engineering Manager should have:Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field).At least 10 years of experience in an engineering role, with a minimum of 3 years in a managerial or leadership position, preferably within the medical device industry.Strong understanding of medical device development, manufacturing processes, and regulatory compliance.Proven experience in managing engineering projects for medical devices, from design to commercial release.Experience with risk management processes, including risk analysis and mitigation strategies, in the medical device industry. Proficiency in CAD software and other relevant engineering tools.Direct experience with tooling setup and management, including tool design, validation, and maintenance.Experience in moulding injection, extrusion, and assembly processes is highly desirable.Demonstrated ability to lead NPI transfers from other manufacturing locations.Strong leadership, communication, and stakeholder management skills.High attention to detail with strong organizational and problem-solving abilities.Ability to work under pressure in a fast-paced, regulated environment.What's on OfferA competitive salary.Additional 13th month salary as a part of the benefits package.A supportive and inclusive work environment that encourages growth and development.Opportunities to work on innovative projects in the life science industry.Permanent role with stability and career progression opportunities.We invite passionate and dedicated professionals in the engineering and manufacturing sector to seize this exciting opportunity. Apply today to join our team and contribute to our mission of innovation and excellence in the life science industry.ContactJoanna DarmarajahQuote job refJN-042025-6717815Phone number+60323024048Job summaryFunctionEngineering & ManufacturingSpecialisationOperations ManagementWhat is your area of specialisation?Industrial / ManufacturingLocationPenangContract TypePermanentConsultant nameJoanna DarmarajahConsultant contact+60323024048Job ReferenceJN-042025-6717815
