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

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

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 teams, functions, and with strategic external partners.

•          Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.

•          Make adjustments and assign resources as necessary to ensure the QMS is adequately implemented and monitored.

•          Foster a culture of continuous improvement, encourage the adoption of new tools and methodologies, and promote best practices to improve the quality of software and efficiency of development processes. 

•          Travel expected 25% once the CoE is established; initial travel higher.

Your Team:

The Director, Systems Software Engineering will report to the Sr Director, Software Engineering MPT and lead 4 – 5 direct managers a total team of 45+ employees based globally in Raleigh and Bangalore.

Your Location:

You will work on-site from our office located in Raleigh, NC, one of the national hubs for HealthCare Technology. Relocation assistance will be provided. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

What You’ll Bring:

•          Bachelor’s or Master’s degree in Systems Engineering, Software Engineering, Computer Science, or a related field; Master’s Degree preferred

•          10 years experience minimum, systems engineering, with a focus on software and algorithms in the medical device industry

•          Proven track record of leading and managing engineering teams in a complex, regulated environment

•          Experience in building and structuring engineering teams or departments from inception

•          In-depth knowledge of medical device regulatory standards and risk management processes

•          Strong understanding of systems engineering principles, software development life cycle, and agile methodologies

•          Strong team building and talent management skills, and the ability to motivate team members to achieve goals

•          Must be a strategic, innovative problem solver, and have strong influencing and communication skills

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We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $184,000 - $253,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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