Senior Process Engineer (NPI / Validation / TPM), 12-month, CBD

Job Description:

• NPI / Design Transfer
• Lead end-to-end product & process transfer to TPMs
• Define process specifications, equipment requirements, and manufacturing flows
• Review TPM line design, capacity, and cycle time
• Process & Validation
• Own process documentation: SOPs, WIs, pFMEA, DOE
• Develop & execute IQ / OQ / PQ / TMV
• Ensure readiness for commercial manufacturing
• Manufacturing & Continuous Improvement
• Drive yield, uptime, and failure rate improvements
• Monitor KPIs (FPY, efficiency, etc.)
• Lead process optimization and cost reduction initiatives
• Project & Stakeholder Management
• Act as onsite manufacturing lead with TPM
• Align across Quality, Ops, Supply Chain, global teams
• Track project timelines, risks, and deliverables

Requirements:

• Bachelor's degree in Engineering, Science, or arelated technical field.
• 10+ years of experience in the medical device orsimilar regulated industry, with a focus on manufacturing, NPI, or processengineering roles.
• Hands-on experience in process development, equipmentinstallation and commissioning, and FAT/SAT activities.
• Demonstrated experience leading process improvementand cost-reduction initiatives.
• Solid foundation in general engineering principles.
• Proven expertise in process validation (IQ, OQ, PQ)within a regulated environment.
• Working knowledge of Quality System Regulations (ISO13485 and/or 21 CFR 820), with experience in medical device risk management per ISO 14971

Core Competencies

• Regulatory and Quality Focus - solid understanding of medical device regulations and manufacturing compliance
• Technical Depth - Solid expertise in process development, equipment installation, and validation requirements
• Execution Discipline - Effectively manages complex project timelines with structure and accountability
• Risk-Based Thinking - Skilled in risk assessment, mitigation planning, and decision-making under uncertainty
• Cross-Functional Collaboration - Works effectively across engineering, quality, operations, and global teams
• Adaptability - Thrives in ambiguous environments with evolving requirements and accelerated timelines

Additional Information:

• Salary - Up to S$12K + 1-month bonus
• Contract duration: 12-month contract, extendable
• Commencement Date: Immediate
• Working days and hours: Monday to Friday, 9amto 6pm
• Location: Bugis, frequent traveling to Johor Malaysia