Senior Systems Engineer (Medical Devices)

  • Location

    Singapore

  • Sector:

    Engineering & Manufacturing

  • Job type:

    Permanent

  • Salary:

    S$5000 - S$7500 per month

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH6456_1558678893

  • Published:

    almost 5 years ago

  • Expiry date:

    2019-06-23

  • Consultant:

    ConsultantDrop

My client is a global player in the development and manufacturing of innovative medical devices and life science products catering towards a wide range of industries and as part of a directive to expand innovation across APAC, an experienced Systems Specialist is required who would be responsible for the vital role in defining and developing future products and their life cycle.

Responsibilities:

  • Act as Lead for Design FMEA and ensure cautions are taken against potential risk
  • Application of DFSS principles and tools to assess/select alternatives and to improve the quality of products under development
  • Ensure that assigned products are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing
  • Decompose system requirements and allocates to subsystems. Lead/oversee the development of system requirement specifications by working jointly with the Subsystem Technical Leads to ensure that the content is developed by the appropriate subject matter experts.
  • Identify technical risks and makes recommendations for risk response strategies
  • Work closely with management to integrate product technologies with respect to the engineering teams (eg. mechanical, electrical and software) for robotic projects.
  • Ensure the logical and systematic conversion of market requirements and design input requirements into systems solutions that account for technical, cost and schedule constraints.
  • Investigates and defines systems engineering requirements for features, and facilitates their transition into the project through clinical review and evaluation.
  • Ensure that all features and components are implemented into the product through coordination with the engineering teams.
  • Ensure that products are designed to facilitate manufacturability. May be required to lead or contribute to the process of transferring product from development to manufacturing.
  • Participate in Risk Management activities in the company.
  • Coordinate with management and the engineering teams to create test plans, procedures and reports, and perform verification and validation against requirements.
  • Involvement in intellectual property, service strategy and clinical study support activities.
  • Contribute multi-functional project team activities from early project conceptualization through clinical testing and regulatory submissions and production

Requirements:

  • Advanced Degree in Systems Engineering, Electrical Engineering, Computer Engineering, or equivalent areas.
  • 3 years or more of industry experience in a regulated industry such as medical device, defence, or automotive. Candidates with more relevant work experience or expertise will be considered for a senior level position.
  • Experience with Design Control procedures and requirements engineering.
  • Risk management (risk analysis, FMEA) experience preferred.
  • Strong track record of technical leadership and working in cross-functional teams.
  • Experience developing systems in compliance with IEC (62304, 60601) and other industry standards for electronic medical device equipment is preferred.
  • Prior experience to lead and deliver projects and guide junior members of the team
  • DFSS, Requirement Analysis, Linear Trap Technology, Knowledge Engineering or Systems Engineering experience preferred and a familiarity with ISO 13485 is an advantage
  • Experience in a Phase-Gate development process and design production equivalent rapid prototypes

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).