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Senior Mechanical Engineer

Job details

Location: Singapore
Job Type: Permanent
Discipline:
Reference: HCLF/KP/SME/080519C
Posted: 4 months ago
Consultant: Kelvin Pang
Consultant Email: email Kelvin
Consultant Phone: +65 6950 0364

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.

This job has expired!