Test Engineering Lead- Medical Devices

Job description

POSITION OVERVIEW

Test Engineering Lead Medical Devices

We are seeking an experienced Test Engineering Lead Medical Devices   who can lead software release testing activities. This includes planning and executing necessary test activities, as well as  coordinating with the development team and other test resources.

Our backend software is primarily cloud hosted, integrating data from various devices, trackers, sensors, etc. Our front-end provides mobile apps and web portals so that patients, providers, and payers can interact with the data. Hence, we are looking for an individual with both server-side and mobile device testing capabilities. The ideal candidate will also be able to help us further advance our test automation capabilities so we can keep test cycles as short as possible.

Responsibilities:

·  Responsible for establishing the test strategy, planning and performing Software Verification and Validation at various levels to comply with FDA, ISO and IEC standards for medical devices.
·  Work closely with the software development team to ensure software verification and validation coverage for medical devices (via manual testing, automated testing, code reviews and inspections).
·  Support continuous improvement through enhanced test processes via verification and validation metrics to deliver high quality products to end users.
·  Establish and support processes and metrics around software testing, testing coverage, software defects, defect cycle times, Test Driven Development, Behavioral Driven Development, etc. which help drive needed product quality.
·  Responsible for executing on testing often and early by working in a closely integrated fashion with software developers as well as incrementally building up the verification test protocols in an Agile Software development environment.

Operational:           

·  Demonstrating excellent partnership and collaboration with other functions within the company, as well as with outside contract teams, to support common initiatives on medical devices.
·  Demonstrate customer-focus approach to perform Software Verification and Validation of medical devices.
·  Demonstrating knowledge, skill and ability to model the Sanofi values and positively communicates the company visions, values, priorities and target.

Basic Qualifications

·  BS in computer science or equivalent
·  7+ years of experience in testing complex software products
·  5+ years of hands-on experience in test automation and respective tools
·  4+ years of experience in design controls and FDA’s General Principles of Software Validation/ CFR 820.30 / ISO 13485 / IEC 62304 compliant software development
·  2+ years of experience of testing mobile devices and cloud based applications
·  4+ years of experience in Agile software development and testing

Desired Skills

·  Excellent communication skills to engage and energize cross-functional teams
·  Ability to comprehend complex problems and good problem-solving skills
·  Experience in Agile / Scrum

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.