Position Responsibilities:
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Ensure that device development meets targeted clinical application through systematic conversion of product requirements into systems solutions that meet technical, schedule and cost constraints
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Evaluate device use cases to define system requirements and evaluate technical tradeoffs
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Define Security and compliance requirements for the product; ensure system meets these requirements
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Participate/Lead risk assessments and develop mitigation plans to ensure safe operation of the product
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Participate in strategic discussions and own the technology development for the future generation of the product
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Manage, track and upgrade hardware and software configuration of system / sub-system set-ups in the labs
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Collaborate with quality and regulatory colleagues to ensure compliance with corporate, business unit and global standards applicable to the product
Basic Qualifications:
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B.E. from reputed university in Computer Science, Electronics, Biomedical, Instrumentation Engineering
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3 to 5 years in product development of complex electro-mechanical devices controlled by SW
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Able to work with software and firmware teams to develop the algorithms for controlling the electromechanical components (like heater, pneumatic and hydralulic valves, and reading the sensors)
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Working knowledge of Model based systems engineering approaches, MBSE tools knowledge like MATLAB, Enterprise architect, Cameo
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Able to develop the treatement parameters for Hemodialysis and peritonial dialysis
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Able to write system requirements for performances, able to test and confirm the components performance for temperature, flow, pressure, bubble detection etc.
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Knowledge of medical device quality and regulatory standards (ISO 13485, ISO 14791, IEC 60601, IEC 62304, etc.)
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Strong written and verbal communication skills, with attention to detail and thoroughness
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Able to work in direct, cross-functional and cross-cultural teams, with strong influencing skills
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Able to participate in late evening and/or early morning calls
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Self-starter, strong work ethic and initiative in accomplishing objectives, and delivering in ambiguous environments
Desired Qualifications:
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Working knowledge of define/collection of system requirements especially as applicable to healthcare sector
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Working knowledge of hardware and electromechanical engineering concepts (microprocessors/microcontrollers, wired/wireless communications, motors, sensors, valves, fluid circuits, etc.)
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Full product lifecycle experience (concept/prototyping, development, test, release, post-release)
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Knowledge of Agile methodology for software / product development
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Knowledge of creating automated testing infrastructure
Top Skills
What We Do
Zealogics LLC provides a broad range of IT consulting, systems implementation and application outsourcing services through an optimized global delivery model. Zealogics builds deep knowledge of traditional product engineering across mechanical, electronics and software platforms, to enable clients to navigate their digital transformation.
Zealogics values engineering techniques, automation frameworks, and reference models which are refined through engagements with Fortune 500 enterprises and OEMs. We combine customer-centric product strategies through a collaborative approach for execution. We help to harmonize processes, identify bottlenecks, and eliminate non-value tasks to deliver world-class products.
With impeccable focus on client needs we connect specialized resources for the right positions, both for full time and contractual placements. Our long-term relationships with employees and clients have been built in an environment of integrity and commitment, with a shared goal of mutual success. Zealogics hires experienced people to solve a wide array of IT and Engineering challenges that our clients face. Our guarantee - Zealogics provides the best value services in town.
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