Software QA Manager
Business Unit: Healthineers (HC)
Requisition Number: 235618
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
Siemens Healthineers is looking for a Software QA Manager to lead a team responsible for testing software applications in conjunction with hardware product development for new Molecular Diagnostic instruments.
You will have the opportunity of being part of a startup effort within a large organization and to build your team from scratch. You will be leading a team distributed across multiple locations. As a key leader on our team, you’ll play a crucial role in maintaining and evolving our engineering culture and coaching individuals to achieve their very best. This is a leadership position; though you’ll spend a substantial portion of your time hands-on creating, reviewing and executing test plans including relevant regulatory documentation.
This position will report to the Head of Software Development.
- Recruit & Lead a Software QA team from a technical and people management perspective to build software for medical diagnostic instruments.
· Analyze software requirements to determine feasibility from testing point of view within time and cost constraints.
- Design and improve team process, and enforce technical integrity and standards.
· Develop, review and execute software test plans, test scripts/protocols for manual and automated testing of instrument software including final reports.
· Be the subject matter expert in automated testing. Help the team develop new tests and transition existing manual tests.
· Document and report quality findings to senior and executive management, project/program managers, development team. Follow-up on ongoing issues.
· Responsible for establishing and reporting on key software quality metrics.
· Review of change control documentation for new software/ firmware and modifications to existing validated systems.
· Participation in the development and approval of release notes for new software / firmware versions.
- Collaborate closely with Systems, Software Development, Hardware, R&D and other engineering staff.
- Responsible for the growth and career development of engineers on the team.
Required Knowledge/Skills, Education, and Experience
· 4+ years of experience managing software quality assurance teams.
- 10+ years of overall software QA/testing experience including test planning and test automation.
- Expert understanding of professional software quality assurance and software testing practices and the full software development life cycle.
· Strong expertise in automated testing is a must (e.g. using TestComplete/Selenium).
· Demonstrate understanding of software requirements and best practices:
o Cross-functional Agile development in medical devices.
o Automated testing.
o FDA General Principles for Software Validation.
o FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
o FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
o FDA Guidance for Postmarket Management of Cybersecurity in Medical Devices.
· Experience testing software for complex instruments, equipment, or devices. This includes web/desktop software as well as firmware.
- At least one scripting language, e.g. PowerShell
- Experience with source control, bug tracking and continuous integration systems.
- Experience in a life sciences or regulated (FDA) diagnostic environment.
- Demonstrated ability to manage teams (local and globally distributed), including performance management and recruitment.
- Excellent verbal and written communication with a proven track record of collaborating cross-functionally.
- Desire to join a start-up effort within a major multi-national corporation.
- BA/BS degree (Masters preferred) in Computer Science or equivalent.
- 10% travel expected.
Preferred Knowledge/Skills, Education, and Experience
- Familiarity with Team Foundation Server (TFS).
Experience working with cloud based systems (Azure or AWS).