My client is a growing name in the medical device space and now seek an experienced Mechanical Engineer to join them
State of the art medical products
Innovative R&D
Excellent work culture
Responsibilities:
- Lead the design, development and manufacturing of complex robotic system and instruments
- Lead the product development efforts and work with the manufacturing team to launch robotic systems and instruments
- Work closely with a multidisciplinary team (R&D, Clinical Affairs, Quality Assurance, Regulatory and Marketing departments) to coordinate pilot production of new products
- Solve mechanical engineering problems at the component level through thorough evaluation and troubleshooting
- Conduct testing utilizing new and existing test protocols
- Generate written reports that can clearly contribute to the Design History File
- Complete product enhancement projects in a manner consistent with corporate objectives
- Contribute to the company's intellectual property position via invention and patent applications.
- Create procedures for assembly, inspection and testing of devices.
- Oversee and participate in the pilot and later stage production of the device.
- Provide mechanical engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.
- Provide engineering support in the resolution of product complaints and/or safety issues.
- Maintain GMP systems, including production quality assurance procedures, pre-clinical testing programs and post-production GMP compliance
Requirements:
- Advanced Degree in Mechanical Engineering with 5 - 10 years' of relevant experience.
- Experience with Design Control procedures and requirements engineering
- Robotics and/or medical device experience preferred
- Prior knowhow of Risk management (risk analysis, FMEA) will be a plus
- Experience in developing systems in compliance with IEC (62304, 60601) and other industry standards for electronic medical device equipment will be an advantage
- Knowledge of FEA will be plus
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).