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Senior Mechanical Engineer Medical Devices

Location Singapore, Singapore
Posted 24-May-2019
Description
Senior Mechanical Engineer (Medical Devices)
[Description] SGD5000 to SGD7500 per month

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
Salary details
USD 40000.00 to USD 60000.00

 
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