Manufacturing Engineer

Roles & Responsibilities

JOB SUMMARY

Manufacturing Engineer (Medical) will be responsible for planning, designing, implementing, and managing; integrated, production and service delivery systems that assure performance, reliability, maintainability, schedule adherence and cost control within the production site. The Manufacturing Engineer will adopt as its goals profitability, effectiveness, adaptability, responsiveness, quality, and continuous improvement of products and services throughout their life cycles.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Capable of performing High-Level Assembly (HLA) processes. Develop procedures for these processes and train staff accordingly.
• Strong Knowledge in Healthcare business with ISO 13485 & FDA regulatory would be added advantage.
• Proficient in understanding and interpreting assembly drawings, part drawings, and specifications. Knowledge of medical product assembly is a plus.
• Skilled in report writing, conducting Design for Manufacturability (DFM) analyses, and effectively communicating with internal and external stakeholders.
• Strong understanding of PFMEA, process flow, control plans, and process risk assessments.
• Maintain frequent communication with operations, technical, and quality representatives within the support area through the tier process.
• Provide leadership and commitment to continuous improvements in quality, productivity, and delivery performance by deploying a continuous improvement framework.
• Review all input from the Engineering Department, including Engineering Change Orders (ECOs), new product releases, configuration control policies, and marking requirements, and participate in the DFM process.
• Solid understanding of Bill of Materials (BOM), Engineering Change Notice (ECN) process, Product Change Notification (PCN), and shop floor management is a strong plus.
• Monitor and continuously improve daily quality and efficiency performance for assigned areas. Familiarity with Lean Tools, such as Cycle Time, TAKT Time, and Labor Balance Ratio (LBR), as well as waste reduction, is essential.
• Collaborate with R&D, New Product Development, and Quality teams to provide Design for Manufacturability guidance on new hardware.
• Adhere to all safety and health regulations associated with this position, as directed by the supervisor. Comply with all procedures within the company's security policy

REQUIREMENTS :

Candidate must possess at least a Diploma, Degree, Engineering (Mechatronic / Mechanical) or equivalent. At least 5 years’ work experience in the related field is required for this position.

Tell employers what skills you have

Report Writing

DFM

FDA

Continuous Improvement

Process Flow

High Level Assembly

ISO

PFMEA

Communication Skills

Manufacturing