Ambu is currently looking for a Senior Staff NPI Engineer (Process Development) to be based in Global Hub Penang. This position is part of our R&D NPI team.
Key responsibilities
Your main responsibilities will include:
- Lead process development activities which include designing of the process and equipment, evaluating and optimizing the product design and manufacturing process (Design for Manufacturability and Design for Assembly).
- Be involved in implementation and improvement/optimization of manufacturing processes.
- Define process specifications, set up and qualify process equipment, including carrying out process validation.
- Coordinate activities of suppliers from conceptual discussion and specification through design and reviews to develop, qualify and implement manufacturing processes.
- Collaborate with project stakeholders to ensure process development are carried out effectively and successfully to meet project objectives.
- Resolve quality issues related to new and existing products, including handle NCRs and CAPAs.
- Execute / support assigned tasks including provide technical or engineering support plus problem solving.
- Others ad-hoc tasks as assigned by the superior.
Suggested candidate profile
Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:
- Degree in Engineering Mechanical / Mechatronics Engineering or equivalent.
- Have at least 5 years of related working experience, preferably Medical Device Industry.
- Have strong technical and problem-solving skills to ensure optimal project execution and implementation.
- Knowledgeable on manufacturing processes, equipment, tests and process validation.
- Have strong communication skills, proficient in written and spoken English.
- Able to work independently, be structured and systematic. Able to work in a cross-cultural team.
- Understand documentation work is part of work nature.
- Must have a sense of urgency and commitment to project schedules.
- See it as a challenge to work in a dynamic international environment.
- It will be an advantage to have relevant experience from the Medical Device industry including FDA requirements, Design Control, Process Validation and ISO 13485.
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.