Senior Mechanical Engineer

Job description

Our client is an innovative robotic medical devices start up.

Responsibilities

• 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.

Requirements

• B.Eng/M.Eng/M.Sc (Mechanical) degree with working knowledge of
• Solidworks.
• 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 charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1325516

Only successful candidates will be notified.