Senior Staff Engineer (LSR Molding) - VTTO

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. is recruiting a senior LSR Engineer to lead technical authority for Liquid Silicone Rubber molding across the full medical device lifecycle, from concept to retirement.

You will drive process development, tooling strategy, material selection, and manufacturing to ensure quality and regulatory compliance. The role requires 10+ years in LSR molding and experience with ISO 13485 and FDA regulations, collaborating with R&D, QA, Regulatory, Operations, and Supply Chain to

Qualifications

• Degree or Master in Engineering required.
• Minimum 10 years of experience in LSR molding.
• Experience in medical device manufacturing and regulations (ISO 13485, FDA).

Responsibilities

• Serve as technical authority for LSR molding across product lifecycle.
• Provide leadership in LSR process development, tooling, material selection, and manufacturing.

Skills

LSR molding

Regulatory compliance

DOE

PFMEA

Process validation

Education

Degree / Master in Engineering field

Job description

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)

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