SUMMARY
The systems engineer will be an integral member of my client's engineering team, responsible for verification and validation of all engineering aspects of their implantable artificial heart. With a superior technical ability, the systems engineer is required to develop system specifications, develop test methods and perform or supervise component, integration and system tests of my client's device. This position will undertake and document experiments to verify the device design in order to reliably and repeatedly produce a device, which meets the design input specification. Working closely with management and internal company engineers will assure the long term value and viability of products. My client is looking for motivated team members who are keen to contribute to this active and dynamic project. This role requires creativity and flexibility to find the best solution in a multidisciplinary and dynamic R&D environment. Strong leadership in a team environment, organizational, time/project management and technical skills are required.

RESPONSIBILITIES

• Specification of component and system test requirements.
  • Analyze product specifications in cooperation with teams from electrical, mechanical, software engineering.
  • Development of system test specifications, feasibility plans and sets of verification and validation tests that meet design input specifications.
• Designing and development of efficient test facilities according to defined specifications.
  • Take technical leadership in the development of validation and verification test facilities.
  • Design test strategies, test procedures and test cases to verify the behaviour of components and systems as compared to the specified requirements.
  • Application of interdisciplinary technical standards, principles, theories, concepts and techniques.
  • Equipment identification, design, installation and validation.
• Conduct and report on experiments for verification and validation of the product input specifications.
  • Plan, schedule, conduct and coordinate detailed phases of work relating to the validation and verification.
  • Create work instruction documentation which describe the testing procedures.
  • Verify test completeness and consistency of devised testing procedures.
  • Technically supervise or liaise with/coordinate the work of technicians.
• Feedback into the development, manufacturing and support divisions of my client's TAH.
  • Develop system models and simulation artefacts to understand the system behavior, system performance or technical attributes.
  • Participate in failure analysis / corrective action activities in order to determine and direct design modifications.
  • Assist in risk analysis and fault analysis studies and support regulatory submissions of specifications, test plans, and reports.

REQUIREMENTS

• Bachelor’s degree in Electrical, Biomedical Engineering or equivalent
• Postgrad qualification desired (Master of Science, Master of Engineering, PhD)
• Working knowledge of process characterisation, pFMEAs, MVP, IQ / OQ / PQ / PPQ, TMVs is desirable.
• An understanding of medical device quality regulations, practices and quality standards, such as ISO 13485, ISO 9001, ISO 14708, IEC 60601-1, and FDA Quality System Regulations.
• Experienced in component, integration and system tests
• Minimum 1 years in medical device development field
• Project and teams management preferred