A Day in the Life SUMMARY OF POSITION The Software Engineer II V V will be responsible for analyzing the requirements, developing the test protocols for product verification and validation of complex electro-mechanical medical devices as per the regulatory standards
ESSENTIAL DUTIES AND RESPONSIBILITIES
Technology Support.
Participate in Sprint planning.
Familiarity and project scope and timelines.
Understanding overall feature requirements, test automation framework and developing automation scripts
Work closely with system and software
Accountable for developing document artifacts as per QMS process.
Make sure the testing protocol covers the requirements
Traceability analysis to make sure no requirements left uncovered.
Automation - work with system and software to define the automation protocols
Proactively identify technical limitations and roadblocks if any bring to the table for discussion and suggest solutions.
Understand the technological and VV challenge. Understand the details as required.
PRINCIPAL WORKING RELATIONSHIPS
Reports to the Engineering Manager
Interface with VV Lead
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.
EXPERIENCE
5-7 years of software testing experience (preferably medical device) including writing tests protocols and execution
At least one year of Test automation experience is added advantage
KNOWLEDGE, SKILL, AND ABILITY
Experience with both manual testing, Analyzing the requirements and deriving test cases as per quality procedure
Identify the ay gaps in requirements or resolve ambiguity in requirements working with the SMEs.
Experience working on Ubuntu/Linux and/or Windows Applications.
OS, Application installation, configuration, preparing the test data.
Experience with Requirements Management tools, configuration management tools.
Experience with modern software testing tools and methods, including validation of object-oriented systems.
Experience in scripting/ programming languages like Python, JavaScript.
Knowledge of object-oriented programming concepts, analytical and logical thinking skills.
Good written and oral communication skills to effectively update status, risks, dependencies.
Organizational skills essential
Self-learning capabilities
Good communication and interpersonal skills
Collaborate with developers, engineering teams
Good team player
Good to Have:
Experience in regulatory industry in an added advantage
Familiarity with FDA regulations and recommended practices, especially regarding software.
Familiarity with ISO 13485, ISO 14971, IEC 62304 and other relevant industry standards
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.
Benefits Compensation
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