Our client is an innovative robotic medical devices start up.
- Lead and contribute to the engineering team in design, development and manufacturing of robotic system and instruments on time and on budget
- Lead the product development efforts and work with the manufacturing team to launch our robotic system and instruments into the market.
- Apply mechanical engineering knowledge to the design and development of new products as well as product changes and enhancements which are consistent with a zero defect level.
- Effectively communicate work with management and the team.
- Work closely with a multidisciplinary team (R&D, Clinical Affairs, Quality Assurance, Regulatory and Marketing departments) to coordinate pilot production of new products and accomplish tasks.
- 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.
- Maintain accurate documentation of concepts, designs, drawings, and processes.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
- 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.
- Oversee outside vendors and consultants as required.
- Maintain GMP systems, including production quality assurance procedures, pre-clinical testing programs and post-production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and European and FDA regulations.
- B.Eng/M.Eng/M.Sc (Mechanical) degree with working knowledge of
- Finite Element Analysis knowledge is a plus
- 5 years or more of industry experience in engineering field.
- Robotics and/or medical device experience preferred.
- Excellent written and verbal communication skills.
- Proven ability of analytical problem solving and troubleshooting.
- Experience with Design Control procedures and requirements Engineering
- Experience developing systems in compliance with IEC (62304, 60601) and other industry standards for electronic medical device equipment is preferred.
- Thorough working knowledge of quality management systems that are ISO 13485 certified is preferred
Please contact Kelvin Pang at +65 6950 0364 or firstname.lastname@example.org for a confidential discussion
EA License no: 16S8066 | Registration no: R1325516
Only successful candidates will be notified.