JOB LOCATION: Bangalore,India
DEPARTMENT: Verification and Validation
REQUIRED EDUCATION: Bachelor’s degree in EC/Biomedical engineering
KEY RESPONSIBILITIES: • Review product, user and technical system requirements for
completeness, feasibility, and testability of the product and/or
system
• Define and implement system integration and test protocols
(including embedded, mobile and web services software, as well
as electrical and mechanical systems)
• Design and develop repeatable test methods/procedures and
automated scripts for product & system verification, considering
both requirements-based and clinical and business use case-based
approaches
• Define and implement system verification and validation
protocols, sampling rationale and acceptance criteria in
coordination with engineering and research teams, and create
associated documentation (plans, protocols, and reports) that
comply with US and international medical device regulations and
corporate quality management systems procedures
• Plan,
develop and execute test protocols to ensure product safety
and effectiveness appropriate to the stage of development for the
device, encompassing software, hardware, and system level
components
• Continually “stress test” and use the device(s) to identify design
and/or manufacturing issues prior to product release
• Assist in the design and implementation of proof-of-concept
simulations and/or prototypes
• Contribute to error budgeting, reliability analysis, design for
manufacturability, and design for cost programs
• Assists in writing and coordinating the submission of Regulatory
documents to FDA and other Regulatory Agencies, including
International Documents (e.g., technical files)
• Work within timelines, resources, and budgets for completion of
assigned projects
• Provides technical leadership on various engineering projects
and/or sub-projects
• Plan and implement process improvements within the V&V;
functions
• Other tasks and resp