Software Test Manager- Medical Device

Job description

Sanofi is in the process of building a medical device technology group that will govern the definition, design and execution of Sanofi's integrated care roadmap for medical devices. Our mission is to build a market leading technology platform enabling differentiated professional services that support patients', providers', payers', and Sanofi's needs to deliver differentiated & improved patient outcomes. To accomplish this, we are establishing core competencies in cloud based data management, data analytics, mobile platform applications, and software based medical device life-cycle, managing internally as well as externally executed projects. The team has broad visibility within Sanofi and we are looking for candidates that are passionate about patients & healthcare, focused on our core values of working as one team and treating others with respect, but last but not least being some of the brightest and most talented resources in the industry.

For this team, we are seeking an experienced software tester who wants to be part of shaping our software test infrastructure for medical devices. First objective will be standing-up the necessary software test infrastructure, processes, and guidelines that can be applied to internally as well as externally executed projects. Once the software test capabilities are in place, objective will then be to contribute to the internal and external software testing of various medical devices in the integrated care space with a focus on diabetes. The software will primarily be cloud hosted, integrating data from various devices, trackers, sensors, etc. and providing mobile and web portals so that patients, providers, and payers can interact with the data. Hence, the testing strategy will need to include server side testing capabilities as well as mobile testing tools and frameworks for iPhone, Android, and html5.

Principal Accountabilities:

·  Establish the initial software testing environment, including processes and tools to support the processes in a most efficient manner. Work with cross-functional stakeholders to get the infrastructure 21 CFR Part 11 compliant
·  Establish software test, verification, and validation guidelines and ensure their implementation through conducting design reviews for source code coming from internal and external sources
·  Work closely with the software development team to ensure proper testing, verification and validation coverage.

Work with internal and external software developers and testers to ensure software testing, verification, and validation deliverables are meeting expectations with respect to quality.

Lead the software testing, verification, and validation aspects of ongoing projects and drive the overall strategy to accomplish satisfactory test coverage.

Lead the Software Testing design control documentations.

Support continuous improvement through software test, verification, and validation metrics and ensure consistent visibility into those for every project executed

Basic Qualifications:

·  Bachelors of Science in computer science or equivalent
·  5-10 years of experience in software testing, verification, and validation
·  5+ years of experience in leading complex software testing projects and other tester
·  5+ years of web and test automation experience
·  2+ years of experience in Agile software development and testing
·  2+ years of experience in design controls and FDA / ISO 13485 / IEC 62304 compliant software development
·  Excellent verbal and written communication skills.
·  Demonstrated initiative and analytical thinking style, able to comprehend complex problems and good problem solving skills
·  Proven track record of being a strong team player.

Preferred Qualifications:

·  MS in Computer Science or equivalent
·  Experience in cloud based deployments of medical software devices
·  Experience in privacy, security, HIPAA, databases, SQL, Objective-C, web apps and mobile apps
·  Establish an Agile culture of testing, testing often and early by working in a closely integrated fashion with software developers as well as incrementally building up the verification test protocols that get informally executed along the progression of the project but formally documented at the end.
·  Complying with policies and processes and ensure they are communicated, understood, implemented, and maintained at all levels of the organization.
·  Demonstrating excellent partnership and collaboration with other functions within the company to support common initiatives on medical devices
·  Demonstrating knowledge, skill and ability to model the Sanofi values and positively communicates the company visions, values, priorities and target. #GD-GZ

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.