Senior Manager, Software V&V Testing

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• Lead the software testing efforts for all Cordella projects (medical software for an implantable class III device), following applicable software verification and validation V&V guidelines

• Manage a team of software test and automation engineers. Grow the team in size and skill 

• Operate as a member of a Scrum Team, building and testing features in very short intervals (hours to days) 

• Strict attention to detail. Educate the team on 21 CFR 820, EU MDR, and modern software testing techniques 

• Point person for test related communications. Forecast testing timelines, liaise with Product teams, and manage test automation projects 

• Produce “documentation audit packages” for software releases including test results and traceability 

• Manage the Test Lab. Design and launch a reliability/performance test lab, with automated devices running various long term load tests.  

• Launch a user-centered software validation program, to ensure the specific needs of our patients and clinicians (our users) are consistently met 

• Lead and architect the direction and strategies of software testing across the organization, possibly providing centralized testing-as-a-service 

• Drive and own improvement initiatives within software and QA 

• Other Incidental duties 

What you'll need (Required):

• Bachelor's degree in computer science or related field and 8 years' related experience required OR Master's degree or equivalent in computer science or related field and 6 years' related experience required

• Other: Certification (e.g. TOGAF, COBIT, ITIL, OCP, etc.) in related disciplines (e.g., programming, database development, project management) required

• Experience with Azure DevOps (ADO), Modern Requirements for ADO, Traceability and Test Plan management in ADO  

• Professional Certifications or Personal Portfolio. Evidence of software testing craftsmanship, deep understanding, achievement, or technical creativity 

What else we look for (Preferred):

• Ability to quickly synthesize information from a variety of sources, create a plan of action, and follow through 

• Demonstrate solid performance in an architect role working with cross-functional teams on enterprise-level or complex/novel system implementations 

• Relevant industry experience (e.g. medical device, pharmaceuticals, etc.) or in highly regulated environments 

• Professional Scrum Master (PSMI) or experience on a Scrum team 

• Advanced Testing related certifications or achievements 

• Software development & coding experience 

• Experience testing business IT systems (providing evidence for HITRUST, SOC2, and other IT-audit related projects) 

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control <