• Support the design, development, and validation of Software as a Medical Device (SaMD) solutions, ensuring compliance with relevant medical device regulations and standards (e.g., ISO 13485, IEC 62304). • Collaborate with cross-functional teams, including ML scientists, software developers, clinical experts, regulatory affairs, and quality assurance, to ensure seamless integration of system requirements. • Coordinate and document the development of system architecture that ensures scalability, reliability, and compliance with safety and performance standards. • Define and document system requirements, functional specifications, risk management strategies, and validation procedures. • Conduct risk assessments and manage risk mitigation activities related to system safety and performance. • Ensure compliance with FDA and other international medical device regulations and guidelines for SaMD. • Oversee verification and validation testing, ensuring traceability from requirements to system performance. • Provide technical support during regulatory submissions and audits, collaborating with regulatory teams to ensure successful clearance. • Stay current with technological advancements, industry trends, and evolving regulatory requirements for medical devices. • Develop design control documentation, including system requirements, design reviews, and traceability matrices. • Support post-market surveillance activities, including software updates, patches, and enhancements.

• Provide Tier III troubleshooting support • Advise stakeholders on technical direction for IT services and solutions • Partner with Security to implement best practices and remediate any gaps • Integrate various best of breed SaaS products for a seamless user experience • Automate all IT processes from hardware acquisition, user provisioning, onboarding/offboarding, and any other manual process • Help guide the implementation and integration of AI workflows within the company. • Work independently and collaboratively on long term projects that support business objectives.

• Work with a cross-functional team on large scale projects. • Identify potential projects risks and contingencies. • Elicit and document detailed business requirements to support system and process changes for cross-functional projects. • Considers root cause analysis and identifies process improvement opportunities. • Apply practical application and industry knowledge to decision making and strategic initiatives. • Make complete technical and business process recommendations including ROI, estimated time required and other documentation that supports the project life cycle. • Serve as liaison between business process experts and technology experts in order to elicit business requirements and translate to technical teams. • Develop the test strategy and planning documents. • Coordinate and communicate test strategy to project sponsors, and management. • Ability to serve as a Test Lead on complex projects and provide test execution support as needed. • Ability to write test plans and enter into defined testing tools. • Assign testing tasks as needed to project testers. • Monitor activities assigned to testers and ensure testing is completed by the due date. • Review and coordinate testing with business areas. • Communicate test status and milestones to department and project management.

• You categorize, prioritize and process incoming service requests efficiently and with a solutions-oriented approach • You analyze existing IT infrastructures and customer environments to identify optimization potential • You provide remote support to our customers and, when required (with prior notice), perform occasional on-site visits • You handle incidents, change requests and general inquiries — always maintaining high quality standards • You create clear, practical documentation and guides for colleagues and customers • You lead and support IT projects — from planning and implementation through to successful handover — both internally and at our international client sites • You ensure structured project communication, coordinate involved teams and ensure timely delivery • You grow with us — taking on new challenges, developing professionally, and engaging in active team collaboration • You use your creative freedom to contribute ideas and further develop our services and project processes • You work independently and in a structured way, taking ownership of your tasks and projects