Principal Engineer, LSR (ISO13485)

Our client is a Manufacturing MNC, one of the leading players in the Contract Manufacturing sector. Due to business needs, they are now recruiting a LSR Engineer to be part of their Engineering team for ongoing transformation projects. They are located in the North – easily accessible.

Duties of LSR Engineer

• Serve as the technical authority for Liquid Silicone Rubber (LSR) molding across the full medical device product lifecycle, from concept development through commercialization, sustaining engineering, and product retirement.
• Provide technical leadership in LSR process development, tooling, material selection, and manufacturing to ensure product quality, regulatory compliance, and cost-effective production.
• Partner with R&D, Quality, Regulatory Affairs, Operations, and Supply Chain teams to support new product development, process transfer, and continuous improvement initiatives.
• Drive Design for Manufacturability (DFM) and Design for Reliability principles, providing expertise in component design, tooling strategies, material selection, and biocompatibility considerations.
• Lead process development and validation activities, including DOE, PFMEA, process capability studies, and IQ/OQ/PQ validation, utilizing scientific molding principles.
• Ensure compliance with ISO 13485, FDA Quality System requirements, ISO 14971 risk management standards, and other applicable medical device regulations.
• Support audits, regulatory inspections, CAPA investigations, root cause analysis, and post-market manufacturing performance activities.
• Review and approve engineering changes, ensuring appropriate risk assessments, validation requirements, and regulatory considerations are addressed.
• Provide technical oversight to suppliers, contract manufacturers, toolmakers, and material vendors, including qualification, audits, technology transfers, and performance improvement initiatives.
• Evaluate and implement advanced LSR technologies, automation solutions, and process innovations to support business growth and operational excellence.
• Act as the Subject Matter Expert (SME) for LSR molding, providing mentorship, technical guidance, and recommendations to cross-functional teams and senior leadership.

Requirements

• Degree / Master in Engineering field
• Min 10 years of experience in LSR molding
• Experience in medical device manufacturing and regulations (ISO 13485, FDA)

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 candidate will be notified.

Email Address: [email protected]

EA License No: 19C9682
EA Personnel No: R2198636
EA Personnel Name: Oh Puey Xin