My client is a world leader in the design and manufacturing of complex medical devices and equipment and are expanding in Singapore. Intending to make Singapore a regional hub for R&D, they now seek an experienced Process Development Engineer to join them.
- Global Name in Medical Devices
- Great career parth
- Attractive package
- Lead and/or participate in R&D projects - design development, design verification, technology introduction, process optimization, product introduction, product validation and product approval
- Develop, qualify and integrate new technologies, processes and materials ensuring compliance with the external standards, internal rules, design rules and internal requirements
- Execute policies, processes, methods and generate documentation according to existing standards in order to maintain common standards
- Lead and support the product development through aspects of product design criteria, product function and customer needs, complaint assessments and supplier contacts
- Support product design verification and validation taking design and production processes into consideration
- Develop new tests and analyse data using statistical techniques and communicate results to cross-functional teams
- Conduct risk assessment of the product and the product components
- Provide technical expertise or support related to manufacturing
- Analyse statistical data and product specifications to determine standards and establish quality and reliability objectives
- Ensure that standard operating procedures and company policies are adhered to
- Establish and maintain effective communication with project team members, manufacturing and quality department, management and other stakeholders.
- Degree in Mechanical, Electrical or equivalent, with at least 5 years' experience in R&D, Product Development of medical devices or related equipment
- Exposure to a GMP and ISO13485 regulated environment
- Expertise in the development of medical products and approval processes in an international environment
- Experience in high volume manufacturing and assembly processes
- Prior knowledge in automation and digitalization
- Knowledge in the verification and validation of medical devices
- Excellent interpersonal skills with a strong systematic mind set
- Proficient in Project Management
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).