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Job description Project Engineer Fong's Engineering And Manufacturing Pte. Ltd
- Lead development activities to generate solutions to design problems, design evaluations (such as tolerance analysis, FEA, simulated use testing, etc.), craft risk analysis documentation and support the development of product verification/validation plans and testing.
- Define timelines for development activities and provide regular updates on the status of those activities.
- Work with engineering and suppliers to tackle manufacturability issues and then collaborate with manufacturing partners during Design Transfer phase
- Familiarize with Design Control requirements and ensure compliance for entire project.
- Actively participate in Post-Market Surveillance reviews and provide product support to the field.
- Work directly with the Cross Functional Team to gather key data for Project Core Team
- Perform other duties as assigned.
- Communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/or teams, and work effectively as a team member.
- Prioritize tasks and handle a dynamic workload.
- Have a minimum of a bachelor's degree in Biomedical Engineering, Mechanical Engineering or equivalent.
- Have at least 2 years of engineering work experience in new product development, manufacturing engineering or related experience.
- Have prior experience in a highly regulated industry. Engineering experience in medical devices is preferred.
- Possess a successful track record working with multi-functional teams within the R&D or product development environment .