Manufacturing Engineer

Titanium Systems Sdn Bhd; Johor; On-site; MYR 60,000 - 100,000; Full time

Job summary

Titanium Systems Sdn Bhd is seeking a Manufacturing Engineer to own root cause analysis, implement countermeasures for quality defects, and perform incoming inspections on consumables. This role focuses on ISO-13485 regulated processes with contract manufacturers to ensure product quality and regulatory compliance.

Responsibilities include leading root cause investigations, deploying robust countermeasures, and mentoring production teams on quality practices while collaborating with design,

Qualifications

• Bachelor's degree in Engineering, Science, or related field required.
• 5+ years of manufacturing or quality engineering experience, preferably medical devices.
• Proven ability to perform root cause analysis and develop effective countermeasures.
• Strong attention to detail and documentation accuracy.

Responsibilities

• Lead investigations to determine root causes of quality defects using structured problem-solving techniques (5 Whys, Fishbone, FMEA).
• Develop and implement robust countermeasures to prevent recurrence with cross-functional teams.
• Perform detailed incoming inspections on consumable assemblies to verify performance specifications.
• Drive continuous improvement to enhance product quality and manufacturing efficiency at global CM facilities.
• Maintain records of investigations, corrective actions, and inspection results; present reports to management.

Skills

Root cause analysis

Quality mindset

Cross-functional teamwork

Documentation

Education

Bachelor's degree

Tools

FMEA

Job description

We are seeking a talented and driven Manufacturing Engineer to join our team and take ownership of root cause analysis, implement countermeasures for quality defects, and perform incoming inspections on parts for consumables produced by ISO-13485-regulated contract manufacturers.

The primary focus of this position will be investigating quality defects, identifying root causes, and implementing effective countermeasures to prevent recurrence. You will also perform incoming inspections on parts and materials, ensuring they meet quality and regulatory standards before they enter production. This role is vital to maintaining the integrity of our products and ensuring that manufacturing operations run smoothly and efficiently. Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

• Lead investigations to determine the root cause of quality defects or production issues using structured problem-solving techniques (e.g., 5 Whys, Fishbone diagram, and proactively utilizing Failure Mode and Effect Analysis - FMEA)
• Develop and implement robust countermeasures for identified quality issues to prevent future defects. Collaborate with cross-functional teams to ensure solutions are effective and sustainable.
• Perform detailed incoming inspections on consumable assemblies to verify they meet performance specifications.
• Drive continuous improvement efforts to enhance product quality, manufacturing efficiency, and overall operational performance at global contract manufacturers. Lead initiatives to reduce defects and improve yield.
• Maintain detailed records of quality investigations, root cause analysis, corrective actions, and inspection results. Prepare and present reports on quality performance to management and other stakeholders.
• Provide training and guidance to production teams on quality standards, best practices, and defect prevention techniques. Support production teams in troubleshooting quality issues during manufacturing runs.
• Work closely with design, engineering, and production teams to ensure manufacturability and quality of new products. Collaborate with vendors and suppliers to address quality concerns related to incoming materials.
• Create and maintain BOMs, standard operating procedures (SOPs), work instructions, and other documentation to ensure consistency and regulatory compliance.
• Support the introduction of new products into manufacturing, including pilot runs, scale-up processes, and transfer to full-scale production.
• Collaborate with CMs and Factory Engineering team to ramp new manufacturing production lines and equipment to targets to meet business needs, analyze yield and OEE issues to identify areas and opportunity for continuous improvement and implement resolutions.
• Support manufacturing lines and key processes at suppliers, contract manufacturers, and internal manufacturing.
• Review and approve supplier process controls, and be responsible for reviewing and approving engineering change orders.
• Create Requirements and Qualification plans for automated testing equipment located at contract manufacturers.

Requirements

• Bachelor's degree in Engineering, Science, or a relevant field. An advanced degree is preferred.
• 5 years of experience in a manufacturing or quality engineering role, preferably within the medical device or consumables industry.
• Proven ability to perform root cause analysis and develop effective countermeasures to resolve quality issues.
• Strong attention to detail with the ability to identify defects and inconsistencies, ensuring products meet required specifications.
• Excellent communication skills, both written and verbal, with the ability to clearly document findings, present solutions, and collaborate with cross-functional teams.
• Ability to work effectively with teams across different functions, including contract manufacturers, quality assurance, engineering, and supply chain.
• Flexibility to travel up to 20% of the time, including international travel, to support company projects and initiatives.

Preferred Skills/Experience

• Experience with regulatory standards such as ISO 13485 and/or FDA 21 CFR Part 820.
• Knowledge of medical device or consumable manufacturing processes (e.g., injection molding, assembly, sterilization)