Senior NPI Engineer (Process Development)
Country:
Malaysia
Location:
Penang, MY
City:
Penang
Business Area:
R&D
Employment type:
Full-time
Responsibilities:
- Lead 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 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.
Requirements:
- A 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.