Hardware Architect

Job Requirements Compile Hardware Requirement Specification HRS by understanding the system requirements user needs product technical specifications medical device standards and regulatory requirements Create high level product hardware architecture considering various sub-system hardware elements required to realize the product Conceptualize hardware sub-system elements as part of overall system hardware architecture with an intent to achieve robust and reliable system design with optimal segregation of power analog and digital signals for improved signal integrity and reduced noise coupling Hardware design for interfacing sensors and actuators Support software engineering team to identify and freeze on the hardware interface for sensing control during software development work together in selection of microcontrollers microprocessors memory I O and other peripherals around the digital hardware support in building proof of concept testing of informal formal software development builds Lead and guide a team of Hardware Engineers and PCB designers in carrying out day-to-day project activities Guide PCB designers during placement and routing to ensure compliance with medical device standards Review and scrutinize the activities artifacts and deliverables generated by Hardware Engineers and PCB designers Work closely with mechanical and system engineers for optimal layout and placement of the various hardware sub-systems within the system product enclosure for optimum user patient safety noise immunity susceptibility manufacturability serviceability and product compliance Formulate test methods and make provisions for test points in design for hardware testing and board bring-up during development prototyping as well as manufacturing Work Experience Bachelors Diploma degree in Electrical Electronics Telecommunication Biomedical with overall 15years of experience in designing building hardware for medical devices catering to critical life-saving clinical applications First-time-right design with in-depth understanding of medical device standards viz IEC 60601-1 IEC 60601-1-2 ISO 14971 along with associated collateral and particular standards Proven track record of designing and delivering medical device hardware for safe use by operators and patients meeting or exceeding the essential performance parameters of the product less susceptibility to external sources of noise and electro-magnetic disturbances and generating minimal noise and electro-magnetic disturbances to the external environment Proven track record of designing and deploying analog digital power electronics and mixed signal circuit for medical device applications Ability to estimate power requirements for the overall system and accordingly define the specifications for the SMPS Ability to own the complete hardware risk management activities workflow and documentation independently with minimal guidance and support from the Systems Risk Engineers Ability to identify hazards hazardous situations conduct in-depth dFMEA and identify risk control measures RCMs Ensure the RCMs are implemented and made effective in the hardware during the design phase itself Hardware reliability engineering expertise with effective calculation of MTBF and other reliability parameters for various components and systems of the product hardware able to estimate the life of the product including the various sub-systems along with the periodic preventive maintenance service intervals for hardware post its launch to market Expertise in pre-design and post-design compliance to EMC Desired Skills Good understanding of various communication bus topologies critical aspects related to them to be taken care in the hardware design Exposure to external lab testing for the hardware to comply with IEC 60601-1 Basic safety Essential performance and IEC 60601-1-2 EMI compliance Building hardware simulators test jigs fixtures useful during sub-system system testing verification validation Experience building of custom off-the-shelf SMPS for medical applications Interaction with magnetics power supply vendors for realizing the same