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.
- 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
- 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).