NPI Engineer (Process Development)

Ambu A/S; George Town; On-site; MYR 30,000 - 60,000; Full time

Job summary

Join a visionary and rapidly expanding company as an NPI Engineer in the Process Development team. This role offers the chance to drive innovative process development and optimization in a dynamic international environment. You'll collaborate with skilled colleagues and contribute to exciting projects that shape the future of medical devices. With a focus on personal and professional growth, this position provides a supportive atmosphere where your contributions truly matter. If you're passionate about engineering and eager to make a difference, this opportunity could be your next big step!

Benefits

Personal Development Opportunities

Social Employee Benefits

Financial Employee Benefits

Informal Working Environment

Qualifications

• Degree in Engineering required; fresh graduates welcome.
• Experience in Medical Device or Healthcare Industry preferred.

Responsibilities

• Drive process development activities and optimize manufacturing processes.
• Collaborate with stakeholders to meet project objectives effectively.

Skills

Mechanical Engineering

Mechatronics Engineering

Manufacturing Engineering

Technical Problem-Solving

Documentation Skills

Knowledge of FDA Requirements

Process Validation

ISO 13485 Knowledge

Good Communication Skills

Ability to Work Independently

Education

Degree in Engineering (Mechanical/Mechatronics/Manufacturing)

Job description

Ambu A/S is currently looking for an NPI Engineer for our Process Development team to be based in Ambu Global Hub, in Penang, Malaysia.

Key Responsibilities

Your main responsibilities will include:

• Participate in and drive process development activities which includes 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 is carried out effectively and successfully to meet project objectives.
• Resolve quality issues related to new and existing products, including handling NCRs and CAPAs.
• Execute/support assigned tasks including providing technical or engineering support plus problem solving.
  
  

Suggested Candidate Profile

Skills

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:

• A degree in Engineering Mechanical / Mechatronics / Manufacturing Engineering or equivalent.
• Fresh graduates are also welcome to apply. However, working experience in Medical Device or Healthcare Industry will be given priority.
• For experienced candidates, technical and documentation skills are good to have to ensure optimal project execution and implementation. It will be an advantage to have relevant experience in FDA requirements, Design Control, Process Validation and ISO 13485.
• Having technical problem-solving skills to ensure optimal project execution and implementation.
• Knowledge in manufacturing processes, equipment, tests and process validation are added advantages.
• Good communication skills in English, written and spoken.
• Able to work with minimal supervision, be structured and systematic. Able to work in a cross-cultural team.
• Understands urgency and commitment to project schedules.
• Able to work in a dynamic international 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.