Senior Biosafety & Sustainability Engineer I

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

Senior Biosafety & Sustainability Engineer I

City: Penang Country/Region: Malaysia State: Business Area: R&D Department: Biosafety and Sustainability Employment Type: Full-time Req ID: 10612

Ambu A/S is currently looking for a Senior Biosafety & Sustainability Engineer I to be based in our Global Hub, Penang. You will be reporting to the Section Manager, Biosafety & Sustainability.

Key responsibilities

• Prepare biological evaluation report, toxicological risk assessment, biological equivalence report, FDA 510k submission and material compatibility assessment.
• Support the biological safety and material compliance evaluation of medical devices throughout the product lifecycle, including risk assessment.
• Plan, execute, and interpret biological and chemical assessments.
• Contribute to project planning by identifying biosafety-related activities, risks, dependencies, testing needs, and timelines for product development and change projects.
• Collaborate with cross-functional teams and external partners to support project execution, regulatory submissions, audits, and customer inquiries.
• Monitor and interpret relevant regulations, standards (ISO 10993, ISO 18562), and industry developments related to medical device safety, materials, and chemical compliance (REACH, RoHS, CLP).
• Support the collection, review, and management of product sustainability data and documentation to ensure accuracy and completeness throughout the product lifecycle.
• Evaluate product, material, and manufacturing changes for potential impacts on sustainability-related documentation and requirements, and support implementation of necessary updates.

Suggested candidate profile

• Bachelor's or Master's degree in Polymer Science, Polymer Engineering, Materials Science, Materials Chemistry, Chemical Engineering, Toxicology, Biomedical Engineering, or a related scientific discipline.
• Knowledge of medical device regulations and standards such as ISO 10993, ISO 18562, ISO 14971, ISO 13485, FDA guidance, REACH, and RoHS.
• Understanding of polymer and material technologies commonly used in medical devices.
• Familiarity with material characterization, chemical composition, toxicological risk assessment, chemical characterization, or analytical testing.
• Ability to evaluate and interpret technical, scientific, and regulatory information from multiple sources.
• Relevant experience from medical device or pharmaceutical company.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills in English.
• Interested in sustainability
• Good with excel skills and AI skills
• Able to work effectively in a global, cross-functional environment.

Ambu – a visionary and international workplace where your efforts matter Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment. We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

For more information, please visit ambu.com or follow us on LinkedIn .