Job Description

Responsibilities:

• Perform system level testing and verification on design changes (with R&D approval). Implement tests that validate the quality and the functionality of product. In collaboration with R&D, lead team in system verification and validation testing design and execution to ensure product performance meets requirements.
• Collaborate with R&D on new product launch and transfer to manufacturing.
• Provide technical support to Mfg. site and work on Product sustaining and troubleshoot manufacturing issues to support Mfg. Engineering
• Update/maintain design specification and technical documentation of on-market products
• Design Integration testing and roadmap in collaboration with Project Management to ensure successful adherence to time management and key milestones. Ensure smooth transition from NPI to Production
• In collaboration with R&D, develop design input requirements and design specifications consistent with company guidelines, regulations, and user needs and manage the subsystem extrapolations and implementations of those requirements where appropriate. Drive alignment between subsystem plans and design input requirements for design changes
• Support cross functional teams and work as a system engineering subject matter expert to evaluate, troubleshoot, and suggest improvements for on market products
• Lead the FMEA and risk analysis for any design changes
• Support CM in managing supplier change notification whenever there is EOL/ obsolescence and coordinate with LCM, Supply Assurance and Commodity teams to ensure minimum disruption to the supply chain.
• Collaborate with suppliers to address technical problems, root cause of quality issues and recommend timely corrective action is taken to secure continuity of supply.

• Bachelor\xe2\x80\x99s degree in Engineering (Mechanical, Electrical/Electronics, Biomedical). Master\xe2\x80\x99s degree is preferred
• At least 8+ years systems engineering experience leading and supporting multidisciplinary teams, external development partners, and manufacturing partners
• Must have a high level of self-discipline, drive, and a proven ability to lead teams
• Strong background in system design and validation of complex medical devices (programmable electromechanical systems). IVD experience preferred
• Experience working in FDA regulated environment with knowledge of 21 CFR 820 Part 11 is required
• Experience with HW and SW interfaces, as well as the HW and SW architecture is required
• Experience with using lifecycle management tools for requirement management and traceability (e.g. JAMA) is required
• Experience using change control management tools to problem resolution activities desired
• Experience with system testing processes and tools is preferred
• Experience with usability testing processes and tools is preferred
• Experience in applying Agile principles to developing medical devices including HW engineering is preferred
• Ability to effectively communicate and translate across functions including design engineering, marketing, software, Regulatory and other global teams
• Ability to integrate global standards and regulations into design
• Knowledge of FDA QMS requirements, ISO-13485, European Medical Device Regulations and Canadian Medical Devices Regulations
• Design transfer and production ramp-up experience is desirable
• Positive attitude and communication skills in managing multiple stakeholders