Principal Engineer – LSR Process Technology (Medical Devices) | Central

RECRUITPEDIA PTE. LTD.; Singapore; On-site; SGD 150,000 - 230,000; Full time

Job summary

RECRUITPEDIA PTE. LTD. in Singapore is seeking a Principal Engineer – LSR Process Technology to be the technical authority for Liquid Silicone Rubber molding across the full medical device lifecycle.

You will lead process development, validation, NPI, and transfer activities with a focus on robust, compliant manufacturing. The role requires 10+ years in LSR molding, strong knowledge of ISO 13485 and FDA QSR/QMSR, and leadership across global teams.

Qualifications

• Bachelor's or Master's degree in Mechanical, Materials, Polymer, Biomedical Engineering, or related discipline.
• Minimum 10 years of experience in LSR molding, preferably within the medical device industry.
• Strong knowledge of ISO 13485, FDA QSR/QMSR, process validation (IQ/OQ/PQ), and scientific molding.

Responsibilities

• Lead LSR process development, validation (IQ/OQ/PQ), and continuous improvement initiatives.
• Drive New Product Introduction (NPI), Design for Manufacturability (DFM), and process optimization.
• Develop robust manufacturing processes using DOE, PFMEA, Cp/Cpk, and scientific molding principles.
• Support product transfers, supplier qualification, engineering changes, and lifecycle management.
• Ensure compliance with ISO 13485, FDA QSR/QMSR, and medical device regulatory requirements.
• Lead root cause analysis, CAPA, and technical investigations for complex manufacturing issues.
• Partner closely with R&D, Quality, Regulatory Affairs, Operations, and Supply Chain teams.
• Provide technical leadership, mentorship, and support for global engineering projects.

Skills

Leadership

Analytical thinking

Communication

Stakeholder management

Education

Bachelor's or Master's Degree in Mechanical, Materials, Polymer, Biomedical Engineering, or related discipline

Tools

DOE

PFMEA

Cp/Cpk

Scientific molding

Job description

Our client is one of Singapore's top contract manufacturers, with operations across Singapore, Malaysia, and China. They specialize in providing advanced manufacturing solutions for global medical device customers.

Job Description

As the Principal Engineer – LSR Process Technology, you will be the technical authority for Liquid Silicone Rubber (LSR) molding across the complete medical device product lifecycle, from new product development to sustaining engineering and product retirement.

Key Responsibilities:

• Lead LSR process development, validation (IQ/OQ/PQ), and continuous improvement initiatives.
• Drive New Product Introduction (NPI), Design for Manufacturability (DFM), and process optimization.
• Develop robust manufacturing processes using DOE, PFMEA, Cp/Cpk, and scientific molding principles.
• Support product transfers, supplier qualification, engineering changes, and lifecycle management.
• Ensure compliance with ISO 13485, FDA QSR/QMSR, and medical device regulatory requirements.
• Lead root cause analysis, CAPA, and technical investigations for complex manufacturing issues.
• Partner closely with R&D, Quality, Regulatory Affairs, Operations, and Supply Chain teams.
• Provide technical leadership, mentorship, and support for global engineering projects.

Job Requirements

• Bachelor's or Master's Degree in Mechanical, Materials, Polymer, Biomedical Engineering, or related discipline.
• Minimum 10 years of experience in LSR molding, preferably within the medical device industry.
• Strong knowledge of ISO 13485, FDA QSR/QMSR, process validation (IQ/OQ/PQ), and scientific molding.
• Experience in process development, tooling, automation, and regulated manufacturing environments.
• Familiar with risk management, engineering change management, and supplier qualification.
• Strong leadership, analytical, communication, and stakeholder management skills.
• Experience leading cross-site or global engineering initiatives is highly preferred.

We regret that only shortlisted candidates will be notified.