Director of Software Engineering (Medical Devices)

Position Summary

The Director of Software Engineering provides strategic, technical, and organizational leadership for software development across the company's product portfolio. The role oversees embedded software while building and integrating capabilities in mobile applications, web applications, cloud platforms, connectivity, data services, and supporting software infrastructure.

The Director is responsible for developing a high-performing global software organization, establishing a scalable software engineering strategy, and ensuring the delivery of secure, reliable, maintainable, and compliant software.

This leader operates across both regulated medical-device software and non-device digital applications. Working closely with Quality Assurance and Regulatory Affairs, Product Management, Systems Engineering, Hardware Engineering and other stakeholders, the Director establishes development practices and governance appropriate to each product's intended use, risk, regulatory classification, and business impact.

The successful candidate combines strong people leadership with practical knowledge of software architecture, modern development practices, agile delivery, cybersecurity, and global medical-device requirements.

The role requires a leader who can set direction and develop the organization while remaining sufficiently close to the technology to guide architectural decisions, challenge assumptions, and support teams in resolving complex issues.

Key Accountabilities

Software Strategy and Organizational Leadership

• Define and execute a software engineering strategy aligned with the company's product, technology, quality, and business strategies.
• Lead the evolution of the software organization from a primarily embedded-software function into an integrated capability spanning embedded, mobile, web, cloud, connectivity, and data solutions.
• Build and sustain a cohesive software engineering organization across internal and external teams through clear structures, roles, career paths, talent development, succession planning, knowledge sharing, and effective capability and capacity management.
• Foster a culture of accountability, collaboration, technical excellence, transparency, continuous improvement, and patient and user focus.

Software Architecture and Technical Leadership

• Establish and maintain the company's software technology and architecture strategy across embedded, mobile, web, cloud, and connected-product environments.
• Ensure that software architectures are secure, modular, scalable, testable, maintainable, and suitable for their intended use and lifecycle.
• Establish technical governance and architecture-review practices while preserving appropriate decision-making authority within development teams.
• Guide decisions involving software platforms, operating systems, cloud services, interfaces, data architectures, communication protocols, development frameworks, and third-party components.
• Promote reuse, shared platforms, common services, well-defined interfaces, and consistent engineering patterns across products.
• Ensure appropriate management of software technical debt, legacy systems, obsolescence, dependencies, and lifecycle risks.
• Participate in major design and architecture reviews and provide guidance on complex technical issues.
• Ensure that significant technical decisions, assumptions, and tradeoffs are appropriately documented.

Software Development Practices and Delivery

• Establish and continuously improve a consistent, scalable software development lifecycle across the organization.
• Implement modern engineering practices appropriate to both regulated and non-regulated software, including agile development, DevSecOps, continuous integration, automated testing, code review, configuration management, release management, and deployment automation.
• Define proportional development pathways based on intended use, product risk, regulatory status, cybersecurity exposure, and business criticality.
• Ensure that regulatory requirements are incorporated where applicable without unnecessarily applying medical-device controls to software that does not require them.
• Partner with Product Managers and Product Owners to translate product strategy and customer needs into achievable software roadmaps and delivery plans.
• Ensure that teams provide credible estimates, identify dependencies and risks, and communicate delivery concerns promptly.
• Establish meaningful software engineering metrics addressing predictability, quality, security, productivity, maintainability, and delivery performance.
• Remove systemic obstacles and improve collaboration among Software, Systems, Hardware, Quality, Regulatory, Product, Operations, Service, and Information Technology.
• Oversee external software-development partners and ensure that outsourced work meets applicable technical, quality, security, documentation, and delivery expectations.

Quality and Regulatory Compliance

• Ensure that medical-device software is developed and maintained in accordance with the company's quality management system and applicable global regulations and standards.
• Partner with Quality Assurance and Regulatory Affairs to determine and document the appropriate development controls for each product based on intended use, regulatory classification, safety risk, and market requirements.
• Establish software practices supporting design controls, risk management, requirements management, architecture and design documentation, verification, validation, traceability, configuration management, change control, and post-market maintenance.
• Ensure that software teams are inspection- and audit-ready and that required development evidence is complete, accurate, consistent, and usable.
• Maintain organizational knowledge of relevant requirements and standards, including ISO 13485, IEC 62304, ISO 14971, applicable FDA requirements, the European Medical Device Regulation, and other market-specific requirements.
• Work with Quality and Regulatory leaders to interpret new or changing requirements and translate them into practical software engineering processes.
• Support regulatory submissions, audits, inspections, corrective and preventive actions, complaint investigations, and post-market activities involving software.
• Ensure that software defects and field issues are evaluated promptly for potential safety, quality, regulatory, cybersecurity, and business impact.

Cybersecurity and Product Security

• Establish and maintain a secure software-development lifecycle across embedded, mobile, web, cloud, and connected products.
• Partner with Cybersecurity, Information Technology, Systems Engineering, Quality, Regulatory, and Product teams to define product-security strategy and governance.
• Ensure that security is addressed throughout product planning, architecture, design, implementation, verification, release, deployment, monitoring, and maintenance.
• Establish practices for threat modeling, security risk assessment, secure coding, vulnerability management, penetration testing, software composition analysis, dependency management, and security monitoring.
• Ensure appropriate management of open-source software, third-party components, cloud services, software bills of materials, and known vulnerabilities.
• Maintain processes for vulnerability intake, assessment, remediation, coordinated disclosure, security updates, and post-market cybersecurity monitoring.
• Ensure that software architectures appropriately address authentication, authorization, encryption, privacy, data integrity, availability, logging, update mechanisms, and resilience.

Portfolio and Cross-functional Leadership

• Represent Software Engineering in portfolio, roadmap, architecture, resource, quality, and investment decisions.
• Provide the Portfolio Management Team and Executive Leadership Team with clear information about software capacity, technical feasibility, dependencies, risks, investment needs, and delivery forecasts.
• Work with Functional Engineering Managers and project leadership to assign appropriate software resources to approved priorities.
• Balance investment across new-product development, sustaining engineering, cybersecurity, compliance, defect resolution, infrastructure, technical debt, and capability development.
• Support integration of acquired software teams, products, technologies, and development practices.
• Develop and manage the software engineering budget, including staffing, contractors, tools, platforms, cloud environments, training, and external services.
• Recommend technology investments and organizational changes required to support the company's long-term strategy.

Decision Rights

The Director of Software Engineering:

• Defines the software engineering strategy, organizational model, development standards, technical governance, and capability roadmap.
• Establishes software architecture principles and approves major architecture, platform, and technology decisions within delegated authority.
• Defines development methods, tools, quality expectations, review practices, and technical standards for the software function.
• Establishes proportional software lifecycle models for different product categories in partnership with Quality Assurance and Regulatory Affairs.
• Determines software staffing, organizational assignments, hiring priorities, development plans, and use of external engineering resources within approved budgets and portfolio priorities.
• Approves software tools, platforms, infrastructure, and capability investments within delegated authority.
• Designates software architects, technical leads, reviewers, and subject-matter experts.
• May stop or escalate work when unresolved safety, quality, regulatory, cybersecurity, privacy, architectural, or technical risks make continued development or release inappropriate.
• Approves software technical readiness for release where assigned by the company's development process and delegation-of-authority structure.
• Resolves escalated technical disagreements within Software Engineering.
• Recommends changes to product scope, sequencing, investment, or timelines when technical evidence indicates that an approved plan is not achievable or creates unacceptable risk.
• Does not independently determine a product's regulatory status, approve formal regulatory submissions, change Product Backlog priorities, commit unapproved product scope, or replace the formal authorities of Quality Assurance, Regulatory Affairs, Product Management, or executive governance.

Required Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, Computer Engineering, or a related technical discipline.
• Typically 12 or more years of progressive software-development experience, including at least 5 years leading software engineering managers, technical leaders, or multidisciplinary software organizations.
• Demonstrated leadership of software development within the medical-device industry.
• Experience leading teams responsible for embedded software and at least one additional domain such as mobile applications, web applications, cloud platforms, connected products, or software as a medical device.
• Strong understanding of software architecture, design principles, interfaces, distributed systems, data flows, and system integration.
• Demonstrated experience establishing and improving software development lifecycle processes in a regulated environment.
• Working knowledge of medical-device quality systems, design controls, software lifecycle processes, risk management, verification and validation, traceability, and post-market maintenance.
• Knowledge of relevant regulations and standards, including ISO 13485, IEC 62304, ISO 14971, FDA medical-device requirements, and the European Medical Device Regulation.
• Demonstrated knowledge of product cybersecurity, secure development, threat modeling, vulnerability management, software supply-chain risk, and post-market security.
• Experience implementing agile development practices and modern software engineering approaches such as DevSecOps, continuous integration, automated testing, and release automation.
• Experience leading global or geographically distributed teams and working across organizational and cultural boundaries.
• Demonstrated ability to recruit, coach, develop, and retain software engineering talent.
• Strong business judgment and the ability to balance patient and user safety, compliance, cybersecurity, technical quality, speed, cost, and commercial objectives.
• Excellent communication skills, including the ability to explain complex technical topics, risks, and tradeoffs to executive and non-technical audiences.

Preferred Qualifications

• Master's degree in a relevant technical or business discipline.
• Experience with cloud-native architectures, mobile development, web platforms, connected devices, data services, APIs, and fleet or device-management solutions.
• Experience with software as a medical device, digital-health products, or regulated cloud-based medical-device functionality.
• Experience integrating software teams, products, and development practices following an acquisition.
• Experience creating differentiated governance for medical-device software, non-device healthcare applications, internal tools, and general commercial software.
• Familiarity with IEC 81001-5-1 and other recognized healthcare or medical-device cybersecurity practices.
• Experience with privacy and data-protection requirements applicable to healthcare and connected products.
• Experience managing external software-development organizations and technology vendors.
• Experience modernizing legacy embedded-software architectures and development practices.
• Experience supporting global product registrations, regulatory submissions, inspections, and quality-system audits.

Leadership Competencies

• Enterprise leadership: Connects software strategy and organizational decisions to broader product and business objectives.
• People development: Builds strong leaders, develops technical talent, and creates effective succession and career paths.
• Technical judgment: Understands complex systems and makes sound decisions without becoming the bottleneck for every technical issue.
• Quality and risk mindset: Applies rigor where safety, regulatory, cybersecurity, or business risk requires it.
• Pragmatic governance: Distinguishes between regulated and non-regulated software and applies controls proportionate to intended use and risk.
• Execution focus: Converts strategy into clear priorities, accountable plans, measurable outcomes, and reliable delivery.
• Change leadership: Leads organizational, cultural, architectural, and process transformation effectively.
• Collaboration: Builds productive relationships across Product, Engineering, Quality, Regulatory, Operations, IT, Service, and executive leadership.
• Clear communication: Makes technical challenges, options, and tradeoffs understandable to different audiences.

Measures of Success

Success in this role will be reflected through:

• A clear and implemented software strategy spanning embedded, mobile, web, cloud, and connected-product capabilities.
• Improved software quality, security, predictability, maintainability, and delivery performance.
• Stronger software leadership, organizational capability, employee engagement, retention, and succession coverage.
• Consistent and proportionate development practices across regulated and non-regulated software.
• Reduced critical defects, cybersecurity vulnerabilities, recurring quality issues, and unmanaged technical debt.
• Successful regulatory submissions, audits, inspections, product releases, and post-market software support.
• Improved architectural alignment and reuse across products and platforms.
• Transparent capacity, risk, and delivery reporting that enables sound portfolio decisions.
• Effective integration and development of software teams and technologies across the global organization.

Benefits:

• Dental insurance
• Employee assistance program
• Flexible schedule
• Parental leave
• Retirement plan
• Tuition reimbursement

Application Question(s):

• Please describe your experience leading software development within the medical-device industry, including the types of products or devices you supported.?
• What experience do you have leading embedded software development along with mobile, web, cloud, connected products, or Software as a Medical Device (SaMD)?
• Which medical-device standards and regulations have you worked with directly, such as IEC 62304, ISO 13485, ISO 14971, FDA requirements, and EU MDR?
• 1. Please describe your experience with product cybersecurity and modern software engineering practices, including DevSecOps, CI/CD, threat modeling, vulnerability management, and automated testing?

Education:

• Bachelor's (Preferred)

Work Location: In person