Lead the NPI design transfer process, ensuring that production meets quality and timeline KPIs.
Oversee project management efforts in PQP (Product Quality Planning) and other related projects. Collaborate with the sourcing and quality teams to evaluate and qualify new suppliers. Support internal and external audits, including ISO9001, ISO13485, and ISO14001.
Ensure supplier compliance with company and regulatory standards.
Utilize Lean Six Sigma tools and methodologies to enhance production processes, improve quality, and reduce operational costs. Participate in DFx (Design for Excellence) for NPI projects to optimize product design for manufacturing.
Lead and work with cross-functional teams to drive continuous improvement, manage NPI projects, and support production scale-up.
Contribute to SEP (Supplier Evaluation and Performance) and other relevant initiatives.
Provide technical support to customers, resolving issues such as Return Merchandise Authorization (RMA) and Dead on Arrival (DOA) evaluations.
Communicate effectively with internal and external stakeholders.
Drive process improvements and introduce new manufacturing technologies that align with company goals for productivity, cost control, and sustainability.
Participate in other projects as assigned, supporting broader organizational goals
Basic Qualifications
Bachelor's degree in Engineering (Mechanical, Electrical, or related disciplines) or a degree in Engineering / Science fields.
Minimum of 5 years of experience in a manufacturing or production engineering role
Proven experience in NPI design transfer from R&D to manufacturing
Project Management experience or PMP certification preferred.
Proficiency in Lean Six Sigma methodologies (Green Belt certification or above required)
Experience with statistical process control (SPC) and DFx (Design for Excellence) for product optimization.
Strong knowledge of ISO13485, ISO9001, and other relevant regulatory standards
Experience working with SAP systems for routing, BOM (Bill of Materials), and cost control
Familiarity with analytical instruments to drive improvements in productivity, quality, cost, and performance.
Strong project management and organizational skills
Excellent problem-solving abilities and analytical thinking
Effective communication
Seniority level
Mid-Senior level
Employment type
Full-time
Industries
Medical Equipment Manufacturing
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Senior Engineer • Gelang Patah, Johor, Malaysia
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