Director of Software Engineering

Director, Application Software Engineering

JOB SUMMARY

Directs the activities of the global Application Software Engineering team to achieve the company’s short and long-term business objectives, including development of strategies that support and optimize on-time delivery of projects and optimization of development processes. Supports strategic direction to projects to increase value proposition, market share, and product quality. Ensures all engineering activities are in accordance with organizational standards and industry best practices, with a focus on .Net applications. Develops objectives, plans, and strategies to ensure effective achievement of business goals in partnership with stakeholders across various business areas.

ESSENTIAL DUTIES

• Provide strategic leadership and direction to a globally distributed Application Software Development team, including tech leads, architects, and engineering managers, ensuring alignment with company objectives and industry best practices
• Lead and optimize the performance of cross-functional software development teams across multiple global sites fostering a culture of collaboration, innovation, and continuous improvement.
• Develop and execute short and long-term planning processes that establish technical objectives, project priorities, and milestones for business unit projects, in close collaboration with various Business Areas and stakeholders.
• Oversee the entire software development lifecycle, from conceptualization to commercial deployment, ensuring that all products meet FDA and global regulatory requirements specific to medical software while adhering to the company's Quality System regulations.
• Manage budget, resource allocation, and project timelines across multiple development sites, including cost estimation, staffing decisions, and risk management activities.
• Evaluate and implement proposed solutions, adaptations, and modifications to globally used software products, leveraging technical expertise to drive innovation and product improvement.
• Establish and maintain best practices for software development processes, Design Controls, and Quality Management Systems across all development sites, ensuring consistency and efficiency in a distributed environment.
• Drive the growth and development of the global software engineering team through individualized guidance, training, and supervision, cultivating a high-performance culture that spans geographical boundaries.
• Collaborate with Quality Assurance, Regulatory Affairs, and other cross-functional teams to ensure compliance with industry standards and company policies, while continuously improving processes and product quality.
• Identify and evaluate new product opportunities and emerging technologies, articulating value propositions and potential risks to senior management.
• Manage customer expectations and requirements across various regions, overseeing system change processes, addressing technical product/market concerns, and coordinating release schedules and features.
• Champion change initiatives and drive cultural alignment across the global organization, promoting transparency, collaboration, and engagement in line with R&D senior leadership's vision.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• B.S. degree in Engineering required, preferably in computer science, software or mathematics.
• M.S. or PhD degree in Engineering combined with management degree preferred.

Experience

• Minimum 12 years of progressive experience developing Software products, 7 of which have been in a management capacity.
• Experience in medical device software development is strongly preferred.
• Must have done hands-on software development, particularly with .Net applications.
• Requires experience with program and project management methods and tools in a globally distributed environment.
• Must have important leadership traits, including:
• Command the respect of the technology team with engineering proficiency in .Net, Azure, Kubernetes, cybersecurity and related technologies
• History of developing both technology and people leadership in a distributed team environment
• Documented involvement in process excellence across multiple development sites
• Disciplined execution and drive for results, meeting agreed-upon deadlines despite challenges
• History of success with building products that meet customer needs and quality standards required in a regulated industry
• Partnership credentials with cross-disciplinary teams such as product management, manufacturing, service, IT, legal, clinical, regulatory affairs, quality, project management, HR, and other functions within a global organization
• Demonstrated success in executing distributed team strategies to increase execution capacity and manage globally distributed teams effectively.

Skills

• Demonstrated ability to lead a multi-discipline, globally distributed software development team working on multiple .Net-based projects.
• Ability to solve practical problems and interpret and communicate complex engineering requirements in a manner that allows maximum product flexibility without compromising quality standards.
• Capacity to define and communicate engineering challenges and provide guidance to management in developing and implementing positive and proactive solutions across different geographical locations.
• Demonstrated ability to interact productively and to effectively influence peers, external colleagues, and senior management in a global context.
• Knowledge of current FDA regulatory and ISO requirements and trends affecting medical device software.
• Ability to help management team balance engineering requirements with business requirements and identify solutions to meet both sets of requirements in a globally distributed development environment.
• Strong interpersonal and conflict resolution skills, with the ability to manage across cultures and time zones.
• Advanced understanding and application of Design Controls and Quality Management Systems to medical software product development.
• Demonstrated ability to work collaboratively with business segment, regional, functional product development, and operations leaders to establish long-term goals for the globally distributed product development team.

Exceptional understanding of .Net technology and methods, and the ability to determine appropriate application across various product initiatives.