Quality Engineer II, Software Design Assurance

Position Summary

The Quality Engineer II, Software Design Assurance fulfills software design assurance role on new product development (conception to launch) and sustaining projects. Generates software verification protocols to test all software related requirements and their execution into verification protocols for new and existing products. Utilizes various manual test methods when necessary to support verification efforts (e.g., Manual, Black box, Regression, etc.). This position generates, manages, and controls test suites to support automated unit testing, integration, and system testing, where appropriate to support development activities.

Principal Responsibilities

•    Understands and analyzes software requirements and concepts for development of software verification plans and test execution.
•    Generate, review, execute protocols, investigate test issues, analyze data, and create reports for design verification testing including both firmware and software.
•    Debugs software products through the use of systematic tests to develop, apply, and maintain quality standards for company products. 
•    Develops, modifies, and executes software test plans, automated scripts and programs for testing. 
•    Maintains documentation of test results to assist in debugging and modification of software. 
•    Analyzes test results to ensure existing functionality and recommends corrective action. 
•    Consults with development engineers in resolution of problems. 
•    Produce Design History File (DHF) and Device Master Record (DMR) documentation per quality system requirements.
•    Perform impact assessment of design changes to manage existing protocols.
•    Skilled in test report writing and supporting software change requests working closely with the software engineering team.
•    Provide other departmental support as requested by immediate supervisor.
•    Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.
•    Interface with cross functional groups including R&D, Program Management, Operations, Quality Assurance, Regulatory, Marketing, and Supplier Quality.
 

Education / Experience Requirements

•    BA/BS in Computer Science, Engineering or Physical Sciences preferred.
•    Two years of working experience with software quality assurance required.
•    Clear understanding and working experience of software concepts.
•    Experience testing Medical Devices Software.
•    Advanced degrees and certifications are a plus.
 

Specialized Skills / Other Requirements

•    Clear understanding of black box, acceptance, performance, regression, and usability testing.
•    Knowledge of relevant project management techniques such as Agile, Waterfall, and SCRUM.
•    Knowledge of test automation using scripting languages such as Python preferred.
•    Ability to work independently and with minimal direction.
•    Ability to define, organize, and manage individual tasks.
•    Provide direction to extended and core team members.
•    Effective verbal and written communication.
•    Proficient in technical report writing and review.
•    Interpersonal skills; working in a team and as an individual contributor.
•    Structured and methodical problem-solving approach.
•    Understanding of design controls, software quality assurance, and risk management.
•    Understanding of industry regulations such as ISO13485 and FDA QSR’s.
•    Advanced skills in MS Office, software defect tracking tools preferred.
•    Understanding of IEC 62304 and medical device software standards preferred.
#LI-EB1

Working Conditions / Physical Demands

TRAVEL REQUIRED: None

WORKING ENVIRONMENT:
☒ Office/Professional        ☒ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory