Engineering Manager (FDA) Process improvement

Our client is a well-established MNC specializing in the design and manufacturing of advanced devices. Due to their current expansion plan, they are looking for an Engineering Manager to lead their manufacturing engineering team. They are located in the (North / West) – easily accessible.

Responsibilities:

• Lead the Manufacturing Engineering team in resolving complex production and technical issues while ensuring compliance with medical device quality and regulatory standards.
• Drive New Product Introduction (NPI) activities, including process development, manufacturing readiness, and successful product transfer into production.
• Oversee process optimization, automation initiatives, and continuous improvement projects to enhance manufacturing efficiency, quality, and productivity.
• Collaborate with cross-functional teams to support product development, engineering changes, manufacturing improvements, and customer requirements.
• Develop and implement engineering solutions to improve product reliability, process capability, and manufacturing performance.
• Evaluate new manufacturing technologies, equipment, and automation solutions to strengthen operational capabilities.
• Ensure engineering activities comply with ISO 13485, regulatory requirements, and internal quality management systems.
• Monitor engineering projects, manufacturing performance, and process improvements to achieve operational and business objectives.

Requirements:

• Degree in Engineering or related discipline.
• 5+ years of Class III medical device manufacturing experience, catheter experience is an advantage.
• Experience in NPI and process development.
• Strong experience in manufacturing automation and process improvement.
• Familiar with ISO 13485 and medical device regulations.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/CV.

We regret that only shortlisted candidates will be notified.

Email Address: [email protected]
EA License No: 19C9682
EA Personnel No: R22104769
EA Personnel Name: Ong Boon Kiet (Travys)