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JD as below:
Owns the development and execution of software verification plans by way of verification procedures based upon software and system specifications. Works in the cross functional teams in tight collaboration with Software Design Engineers. Manages team of 15 to 20 verification engineers. Strong product verification background. Must have Medical devices/aerospace/regulatory background.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
· Works as a team member to design, develop and modify Software verification plans, protocols and reports for multiple projects by analyzing software requirements and following the appropriate software development process.
· Executes test protocols, and writes reports to describe program evaluation, testing, and correction.
· Acts as technical contact in the company to provide decisions and recommendations for software verification aspects of projects.
· Participates in software verification plans and protocol reviews and other related design reviews.
· Works with product development teams to evaluate system interfaces, operational requirements, and performance requirements, and testability software.
· Creates, identifies, validates, and uses test tools that facilitate data gathering and test method execution.
· Participates in the design, build, validation and deployment of effective test automation solutions.
· Understands defect management and works closely with Software Engineers on defect resolution.
· Maintains effective communication with the project manager, and team members on project scope, timelines, and design changes.
· Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
· Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead). Networks with key contacts outside of area of expertise.
· Develops technical solutions for complex problems which require the regular use of ingenuity and creativity.
· Provides assistance to other staff with complex tasks that require considerable judgment and initiative.
· Reports work progress, issues and risks to project managers and supervisors.
· Assists with various projects as assigned by direct supervisor.
· Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
· The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Desk Job/computers, lab work.
· Occasionally lift and/or move up to 50 pounds with assistance.
Bachelor's Degree in Electrical Engineering, Computer Engineering, or equivalent technical degree required; Advanced Degree desirable.
EXPERIENCE AND REQUIRED SKILLS:
· With a Bachelor's Degree a minimum 5 – 8 years of related experience required; or with an Advanced Degree a minimum of 3 years of related experience required.
· Demonstrated understanding of principles, theories and concepts in the software engineering field, preferably in the medical device area.
· Software quality assurance experience in a product development environment
· Experience with C, or assembly-level code development, embedded processing and I/O control.
· Experience using tools to test and troubleshoot software applications.
· Excellent organizational and verbal/written communication skills.
· Strong interpersonal skills with ability to work effectively in a team or individually with supervision.
· Highly motivated and energetic. Passion for creating high quality medical device software and systems.
· Experience in development of automated test scripts is preferred.
· Experience and familiarity with ISO 13485 and IEC 62304, and with FDA GMP is preferred.
· Experience with sensors, microprocessor/microcontroller and/or FPGA based digital design is preferred.
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