Application system engineer

Position Responsibilities:
•
Ensure that device development meets targeted clinical application through systematic conversion of product requirements into systems solutions that meet technical, schedule and cost constraints
•
Evaluate device use cases to define system requirements and evaluate technical tradeoffs
•
Define Security and compliance requirements for the product; ensure system meets these requirements
•
Participate/Lead risk assessments and develop mitigation plans to ensure safe operation of the product
•
Participate in strategic discussions and own the technology development for the future generation of the product
•
Manage, track and upgrade hardware and software configuration of system / sub-system set-ups in the labs
•
Collaborate with quality and regulatory colleagues to ensure compliance with corporate, business unit and global standards applicable to the product
Basic Qualifications:
•
B.E. from reputed university in Computer Science, Electronics, Biomedical, Instrumentation Engineering
•
3 to 5 years in product development of complex electro-mechanical devices controlled by SW
•
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)
•
Working knowledge of Model based systems engineering approaches, MBSE tools knowledge like MATLAB, Enterprise architect, Cameo
•
Able to develop the treatement parameters for Hemodialysis and peritonial dialysis
•
Able to write system requirements for performances, able to test and confirm the components performance for temperature, flow, pressure, bubble detection etc.
•
Knowledge of medical device quality and regulatory standards (ISO 13485, ISO 14791, IEC 60601, IEC 62304, etc.)
•
Strong written and verbal communication skills, with attention to detail and thoroughness
•
Able to work in direct, cross-functional and cross-cultural teams, with strong influencing skills
•
Able to participate in late evening and/or early morning calls
•
Self-starter, strong work ethic and initiative in accomplishing objectives, and delivering in ambiguous environments
Desired Qualifications:
•
Working knowledge of define/collection of system requirements especially as applicable to healthcare sector
•
Working knowledge of hardware and electromechanical engineering concepts (microprocessors/microcontrollers, wired/wireless communications, motors, sensors, valves, fluid circuits, etc.)
•
Full product lifecycle experience (concept/prototyping, development, test, release, post-release)
•
Knowledge of Agile methodology for software / product development
•
Knowledge of creating automated testing infrastructure