Job Description

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
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