REQUIRED QUALIFICATIONS:

• University degree in electrical engineering, biomedical engineering or a related field.
• 2+ years of experience in product development within a regulated sector.
• Experience in systems engineering and verification.
• Experience in the areas of requirements writing and analysis.
• Experience in the field of diagnostic testing.
• Excellent problem solving skills in a team environment
• Excellent organizational, communication and collaboration skills

PREFERRED QUALIFICATIONS:

• At least two years of experience in product development in a regulated medical environment.
• Understanding hardware design and tradeoffs, embedded (real-time) software tradeoffs, performance and redundancy issues.
• Deep technical knowledge of advanced testing concepts and formal software and system verification strategies for regulated software, preferably in the medical device industry.
• Extensive knowledge of ISO 13485 and FDA 21, CFR Part. 820 standards.
• Knowledge of ISO 14971 standard.
• Proven ability to interact and influence key stakeholders, both inside and outside the company.

• Participate in project team activities to translate user requirements into design criteria (i.e. hardware, software, mechanical, electrical, interface, etc.) stated in the form of specifications for systems and subsystems.
• Manage system and subsystem requirements and ensure their traceability using a requirements management tool.
• Participate in the development of system design architectures.
• Document and design communication protocols between different subsystems (software, firmware and FPGA).
• Contribute to product risk management documentation – risk analysis, design FMEA and process FMEA.
• Conduct test bench studies and write technical reports.
• Provide expertise in and carry out validation and verification activities.
• Undertake and document design change assessments for new and supported products.
• Manage and maintain the JIRA backlog and prioritize features to be implemented.
• Participate in the reconciliation of subsystem models and the integration of features at the system level.
• Work within a cross-functional team and represent R&D on cross-functional deliverables.
• Continuously improve processes and working methods (applying Agile/Lean principles to eliminate waste) to contribute to the resolution of complex and interdisciplinary problems, while interfacing with peers and cross-functional groups.
• Have a solid understanding of the medical device industry’s design control processes.
• Other duties as required.