Process Engineering Manager

The Process Engineering Manager is responsible for leading the development, qualification, and continuous improvement of manufacturing processes in the EMS factory. This includes supporting both consumer electronics and medical device production. The role ensures all processes meet stringent requirements for quality, cost, efficiency, safety, and regulatory compliance, especially in serving high-end customers. The manager will lead a team of process engineers and work cross-functionally to support New Product Introduction (NPI), process qualification (IQ/OQ/PQ), and sustaining production.

Key Responsibilities:

• Lead the development and industrialization of manufacturing processes for new product launches in both consumer and medical product categories.

• Participate in DFx (Design for Manufacturing/Assembly/Testing) and design transfer reviews with R&D and customer engineering teams.

• Oversee the preparation of Process Flow Charts, PFMEA, Control Plans, and Work Instructions.

• Lead and approve IOPQ (Installation, Operational, and Performance Qualification) activities for new equipment and processes.

• Support EVT/DVT/PVT builds and establish stable processes to transition to mass production.

• Ensure cleanroom and ESD process control standards are met where applicable.

• Monitor and drive improvements in key manufacturing KPIs, including yield, cycle time, OEE, cost, and scrap.

• Apply Lean Six Sigma methodologies to lead root cause analysis, defect reduction, and cost-saving initiatives.

• Collaborate with cross-functional teams to implement automation, ergonomic, and layout improvements.

• Ensure processes remain in a validated state for medical production and conduct re-validation as needed.

• Lead, coach, and develop a team of Process Engineers and Engineering Technicians.

• Allocate engineering resources across multiple production lines and NPI projects.

• Conduct regular performance reviews and provide training in technical and quality disciplines.

• Ensure process documentation is maintained in line with ISO 9001, ISO 13485, IATF 16949, and customer-specific quality systems.

• Prepare documentation required for customer audits, regulatory inspections (e.g., FDA, MDSAP), and internal quality audits.

• Collaborate with QA/RA to ensure traceability, process validation, and engineering change control compliance.

• Work with NPI, Manufacturing, Quality, Test, Automation, SCM, and IT teams to ensure smooth process handoff and operation.

• Interface directly with customers for technical reviews, process capability presentations, and issue resolution.

• Support and respond to customer-specific process audits and continuous improvement initiatives.

Requirements:

• Bachelor’s or Master’s Degree in Mechanical, Electrical, Electronics, or Manufacturing Engineering.

• 8+ years experience in electronics manufacturing, with at least 3–5 years in a managerial role.

• Prior experience supporting both consumer electronics and medical device manufacturing is preferred.

• Proficient in SMT, PCBA, Final Assembly, and Box Build process development and troubleshooting.

• Skilled in PFMEA, Control Plans, DOE, SPC, Lean, Six Sigma, Failure Analysis (8D, Fishbone, etc.).

• Experience with cleanroom processes, process validation (IQ/OQ/PQ), and regulatory requirements for medical devices.

• Familiar with MES/ERP systems, ECN/ECO processes, and documentation control systems.

• Strong leadership, project management, and communication skills.

• Comfortable in a fast-paced, high-expectation environment.

• Able to manage multiple projects with cross-functional coordination.