SUMMARY OF POSITION
The Software Engineer will be a member of the Engineering R&D team working on the software development and support of medical devices. Works closely with other members of the engineering staff to provide technical solutions to engineering problems.
The Software Engineer will participate in the creation of planned documents and validation reports for tool validation activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Participates, as a member of software project or sub-project team(s), in the development of software applications for product / test tools
Adheres to defined development procedures.
Generates high-quality work products.
Translates requirements/specifications into design, and ultimately software.
Participates in requirements, design and code reviews as they pertain to software designs.
Participates in other activities, such as performing hazard and risk analysis, reviews of designs and tests, etc.
Functions well in a team environment
PRINCIPAL WORKING RELATIONSHIPS
Reports to the Sr. Engineering Supervisor/Engineering Manager
Accountable to Project Manager(s) for project-related responsibilities
Frequent interaction with team members from other disciplines, particularly hardware engineers, to develop project requirements and other project artifacts such as project schedules. Possible interaction with clinicians, third-party vendors, manufacturers, subcontractors and other users.
Executing Verification and validation testing of embedded, real-time software, including the development of requirements, test plans and procedures.
Participate in Software tool validation.
Participation in quality assurance functions, including, but not limited to, system risk analysis (per ISO 14971), process audits, static code analysis and test automation.
Participating in design reviews and code inspections and will support the development of documentation required for FDA device approval.
EXPERIENCE
4-8 years of experience in validation of non-product software tools.
Experience in Python programming.
Experience of MATLAB and Simulink Models validation.
Working knowledge of Linux or any RTOS.
Preferred :
Create, review and approve all software development documents associated with each phase of software development, including software verification and validation plans and protocols.
Work closely with software engineers
Document errors and anomalies and assist with corrective and preventative measures. Work closely with other Software Engineers to fix bugs.
Knowledge in C/C++ development environment.
Experience with a documented software development processes or familiarity with FDA and ISO standards like IEC 62304 is a plus
EDUCATION
Required: - B.E or B.Tech in Computer Sciences, Electronics or Electrical Engineer.
Preferred: - M.E or M.Tech in Computer Sciences, Electronics or Electrical Engineer.
SHORT-TERM SUCCESS METRICS (6-12 MONTHS)
Demonstrate strong tool validation skills
Demonstrate strong knowledge on tools and technologies
Establish trusting relationship with the team and other stakeholders
Demonstrate problem solving capabilities.
Deliver on project commitments.
LONG-TERM SUCCESS METRICS (1+ YEAR)
Learn and demonstrate Product and Domain understanding
Consistently deliver on Project commitmentsKeyskills: test cases sql functional testing regression testing java iec 62304 verification validation
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