Director Software Systems Engineering, Novum IQ Infusion Platform and Digital Enterprise (connected electromechanical medical device) (On-Site Raliegh, NC – RELOCATION Assistance Provided)

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Your Role at Baxter:

As the Director, Systems Software Engineering, you will be responsible for establishing and delivering the strategy for all systems related software level R&D deliverables related to the Novum IQ Infusion Platform and Digital Enterprise software for the MPT business. 

This pivotal role involves building and leading multiple teams, overseeing the entire product lifecycle from requirements definition to verification, ensuring that our products meet the highest standards of safety, reliability, and innovation.   You will be responsible for creating and implementing a strategic plan for the functional team and will co-lead and collaborate on initiatives with systems, marketing, IT, Quality, and Regulatory functions.

What You’ll Be Doing:

•          Create, effectively communicate and deploy the strategy for the team that aligns with the overall software organization strategic plan.

•          Oversee the development and optimization of embedded and digital systems within our infusion pump platform to ensure that all software and systems meet stringent regulatory and safety standards for medical devices.

•          Responsible for developing comprehensive software requirements management for new and existing products.

•          Collaborate with cross-functional teams to ensure alignment and traceability of requirements throughout the product development process. 

•          Implement and maintain a robust software risk management framework to identify, analyze, and mitigate potential risks. 

•          Establish and develop the systems engineering team from the ground up based in Raleigh, NC focusing on embedded and enterprise software. 

•          Recruit, mentor, and lead a multi-disciplinary engineering team, fostering a culture of innovation, collaboration, and continuous improvement. 

•          Conduct regular risk assessments and reviews ensuring compliance with medical device regulations and standards. 

•          Ensure robust verification and validation processes are in place to guarantee product quality and compliance with medical device regulations.

•          Oversee and lead the development of test strategies, plans, procedures, and execution.

•          Maintain effective communication with internal and external stakeholders, including regulatory bodies, to ensure product compliance and market readiness. 

•          Actively champion an Agile development culture within the organization, advocating for the benefits of Agile methodologies, and promoting the adoption and integration of Agile practices across the software engineering team.

•          Collaborate with hardware and product systems teams to ensure the successful integration of software into the platform. 

•          Provide leadership for resource staffing and project execution for the team with proactive management of technical and project risk to ensure delivery of business commitments.

•          Identify and manage risks related to software development such as security vulnerabilities, regulatory non-compliance, and project delays.

•          Represent the systems software engineering team in meetings, presentations, and other communications with internal and external stakeholders.

•          Foster a collaborative work environment with strong working relationships within and across t