Director Embedded Software Engineering – Novum Platform – Connected electromechanical medical device

Director Embedded Software Engineering – Novum Platform – Connected electromechanical medical device

Requirements

• 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
• Significant experience in Embedded systems and software engineering with early experience in software development/coding (C++, Python, Linux) in the medical device industry is required
• Understanding of global regulatory requirements for medical devices; risk and reliability concepts for development; and the need to deliver quality products and/or processes
• Significant experience leading a cross functional team and working in a global matrix environment
• Strong team building and talent management skills, and the ability to motivate team members to achieve goals
• Proven experience in driving product specific and overall portfolio strategy in a global business
• Must possess strong knowledge of scientific/technical disciplines and solid knowledge of related disciplines such a regulatory, quality, and/or product development; recognized internally and externally as expert in functional area
• Must be a strategic, innovative problem solver, and have strong influencing and communication skills

Responsibilities

• Build Center of Excellence (CoE) team in Raleigh, NC.
• Leading a team of software managers and engineers, providing technical guidance, and ensuring the team’s work aligns with the program’s goals and objectives.
• Lead software release planning, technical roadmap development and execution of programs spanning across the product platform.
• 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 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.
• Create, effectively communicate and deploy the strategy for the team that aligns with the overall software organization strategic plan.
• Identify and manage risks related to software development such as security vulnerabilities, regulatory non-compliance, and project delays.
• Represent the embedded 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.
• Ensure proper software development and risk management are employed at Baxter.
• 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 15% once the CoE is established; initial travel higher.

Preferred Qualifications

• Master’s Degree preferred