Senior Biosafety & Sustainability Engineer - Med Devices

Ambu A/S; Penang; Hybrid; MYR 150,000 - 210,000; Full time

Job summary

Ambu A/S in Penang seeks a Senior Biosafety & Sustainability Engineer I to join the Global Hub. You will report to the Section Manager, Biosafety & Sustainability, and work on biosafety assessment, regulatory submissions, and sustainability data through the product lifecycle.

Applicants should have a strong background in polymer/material sciences, regulatory standards, and cross-functional teamwork, with excellent English communication. The role supports global projects from Penang.

Qualifications

• Bachelor's or Master's degree in a related scientific discipline.
• Knowledge of medical device regulations and standards (ISO 10993, ISO 18562, ISO 14971, ISO 13485, FDA guidance, REACH, RoHS).
• Understanding of polymer and material technologies used in medical devices.
• Experience evaluating technical, scientific and regulatory information from multiple sources.
• Experience in medical device or pharmaceutical companies is preferred.
• Strong communication skills in English.

Responsibilities

• Prepare biological evaluation reports and toxicological risk assessments.
• Support biosafety and material compliance evaluations across product lifecycles.
• Plan, execute, and interpret biological and chemical assessments.
• Identify biosafety activities, risks, and timelines for development projects.
• Collaborate with cross-functional teams and external partners for submissions and audits.
• Monitor ISO 10993, ISO 18562, and related regulatory developments.
• Support sustainability data collection and documentation across lifecycle.
• Evaluate changes for sustainability impacts and update documentation.

Skills

Analytical thinking

Problem solving

Cross-functional teamwork

English communication

Excel

AI skills

Education

Polymer Science/Engineering

Materials Science/Chemistry

Biomedical Engineering

Toxicology

Chemical Engineering

Job description

Ambu A/S in Penang seeks a Senior Biosafety & Sustainability Engineer I to join the Global Hub. You will report to the Section Manager, Biosafety & Sustainability, and work on biosafety assessment, regulatory submissions, and sustainability data through the product lifecycle.

Applicants should have a strong background in polymer/material sciences, regulatory standards, and cross-functional teamwork, with excellent English communication. The role supports global projects from Penang.