Manufacturing Engineer

Intersurgical Medical Sdn Bhd; Seberang Perai; On-site; MYR 60,000 - 90,000; Full time

Job summary

Intersurgical Medical Sdn Bhd in Penang is seeking a Manufacturing Engineer to optimize end-to-end assembly line operations, ensuring efficient, reliable, and compliant production. You will drive continuous improvement, analyze processes, enhance OEE, reduce downtime, and collaborate across Production, Quality, Maintenance and Engineering to meet OTS and quality targets.

The role emphasizes 6S, standardized work, CAPA, RCA, and data-driven decision making to minimize scrap and cut costs while

Qualifications

• Bachelor's degree in Engineering, Manufacturing or Physical Science.
• Fresh graduates with internship experience welcomed.
• Up to 4 years of related manufacturing experience is a plus.

Responsibilities

• Drive continuous process improvement to meet production goals.
• Improve OEE and reduce downtime on the line.
• Lead 6S, SOPs and standardized work.
• Perform RCA and implement CAPA.
• Collaborate with Maintenance, Production and Quality to resolve issues.

Skills

Lean manufacturing

Problem solving

Analytical thinking

Cross-functional collaboration

Documentation accuracy

Education

Bachelor's degree in Engineering/Manufacturing/Physical Science

Job description

The Manufacturing Engineer is responsible for ensuring efficient, reliable, and cost-effective manufacturing operations by supporting and monitoring the end-to-end production process in an assembly line to ensure smooth plant operations. Ensure production processes and equipment are operating effectively while maintaining compliance with quality, safety, and operational requirements.

Optimizes manufacturing processes to meet production goals, improve quality, cut costs and scrap, and secure On-Time Shipment (OTS).

Drives cross-functional collaboration (Production, Quality, Maintenance, Engineering) to solve manufacturing issues and execute continuous improvement projects.

Manufacturing process development and optimization

Drive continuous process improvement by developing and upgrading manufacturing workflows.

Assess product design, systematically reviewing assembly routing, fabrication, tooling setups, and material needs.

Uncover capacity opportunities to boost manufacturing efficiency, uptime, and overall labor productivity.

Introduce innovative manufacturing techniques and processes to modernize production lines.

Conduct technical engineering assessments targeted at enhancing machine and process capabilities.

Partner with vendors to benchmark and test new machinery, automation, tools and fixtures

Create and maintain quality compliance by developing and maintaining process parameters consistently achieve product specifications.

Mitigate production downtime by troubleshooting and resolving active process defects on the floor.

Map and analyze production workflows to systematically isolate and eliminate line bottlenecks.

Maximize overall equipment effectiveness (OEE) to boost machine utilization and expand production capacity.

Design optimized floor layouts that streamline material flow and maximize manufacturing space utilization.

Compress production cycle times and implement cost-reduction strategies to lower overall manufacturing spend.

Enhance resource allocation by optimizing both manpower staffing levels and material usage.

Track key performance indicators (KPIs) to proactively identify operational gaps and continuous improvement opportunities.

Spearhead Continuous Improvement Projects (CIP) utilizing Lean and Six Sigma methodologies.

Execute targeted waste-reduction initiatives to minimize manufacturing scrap and elevate first-pass yield.

Quality improvement and process control

Create and establish PFMEAs to manage and reduce process risks.

Develop Control Plans to secure standard production quality.

Formulate new process testing and inspection procedures.

Validate production process capability through statistical analysis.

Investigate product non-conformances and active line defects.

Conduct systematic Root Cause Analysis (RCA) on process deviations.

Implement CAPA frameworks to prevent defect recurrence.

Audit manufacturing lines to ensure continuous quality compliance.

Support customer complaint investigations and deliver comprehensive failure analysis reports.

Data analysis and manufacturing performance

Collect and analyze production data to drive fact-based operations.

Track day-to-day manufacturing KPIs to gauge floor efficiency and output metrics.

Proactively spot negative process trends before they impact factory throughput.

Draft comprehensive technical reports and manage engineering documentation changes.

Balance production lines and calculate headcount targets using cycle time studies to eliminate labor waste.

Safeguard On-Time Shipment (OTS) performance across all active lines.

Convert shop-floor numbers into visual dashboards to isolate yield barriers, track scrap drivers, and execute continuous improvement initiatives.

Equipment and process troubleshooting

Track and evaluate equipment, machine, and tooling capabilities to guarantee long-term process sustainment and stability.

Investigate machine-driven production interruptions to systematically minimize equipment downtime.

Isolate sub-optimal process parameters and machine variations that trigger product quality defects.

Partner cross-functionally with Maintenance and Production teams to rapidly diagnose and resolve complex equipment failures.

Engineer process modifications and technical adjustments to unlock higher machine performance and throughput.

Appraise next-generation equipment and manufacturing technologies to keep the facility at the forefront of automation and efficiency.

6S, Safety and Standardized Work Implementation

Lead and implement 6S activities across manufacturing and production areas.

Develop and establish standardized work procedures (SOPs) for manufacturing operations.

Create and implement 6S standards, including Sort, Set in Order, Shine, Standardize, Sustain and Safety.

Develop visual management systems, workplace organization standards and visual controls.

Establish standard work instructions, checklists and inspection criteria.

Develop 6S audit checklists and assessment criteria.

Conduct regular 6S audits to ensure compliance and workplace sustainability.

Identify workplace inefficiencies and implement corrective actions.

Train and guide production operators on 6S practices and standardized work procedures.

Establish ownership and accountability for maintaining workplace standards.

Monitor implementation effectiveness through 6S audit scores and continuous improvement KPIs.

Drive continuous improvement initiatives to improve workplace safety, productivity, efficiency and operational discipline.

Verify production orders.

Ensure correct manufacturing routing and process flow.

Requirements:

Bachelor's Degree in Engineering, Manufacturing, Physical Science, or a related equivalent field. Candidates from Chemical, Mechanical, Electrical and Electronic, or Manufacturing Engineering disciplines are preferred.

Fresh graduates with a minimum of 6 months of internship experience in a manufacturing environment are welcome to apply.

Up to 4 years of experience in manufacturing, production support, process engineering, or a related field will be an added advantage.

Strong understanding of manufacturing processes, Preferably with basic knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.

Ability to read and interpret engineering drawings

Good analytical and problem-solving skills.

Strong attention to detail and documentation accuracy.

Good communication and interpersonal skills.

Ability to work effectively in a cross-functional manufacturing environment.

Knowledge of Lean Manufacturing, ISO 13485, or regulated manufacturing environments is an advantage.