Sr Manager - SW Engineering

Job Description Summary The Senior Manager, Software Engineering will lead a software engineering organization responsible for the development and lifecycle management of software used in a high-acuity care environment.

This role combines engineering leadership, organizational leadership, operational excellence, regulatory compliance, and AI-enabled transformation.

The successful candidate will be accountable for delivering software that is safe, secure, compliant, maintainable, and aligned with business objectives.

The role requires close collaboration with Product Management, Systems Engineering, Quality, Regulatory Affairs, Clinical, Program Management, and Operations.

In addition, the Senior Manager will lead the adoption of AI-augmented engineering practices across software development, verification, documentation, planning, and operational workflows.

The leader will ensure AI is used responsibly, securely, and effectively to improve productivity, quality, decision-making, and delivery performance while maintaining appropriate human oversight, regulatory compliance, and patient safety.

Designs, programs, documents, tests, and fixes bugs involved in creating and maintaining applications and frameworks involved in a software release lifecycle resulting in a digital product.

Impacts approaches, projects and programs in the functional area or affected business organization and ways of working.

Impacts quality, efficiency and effectiveness of own team.

Has significant input into priorities.

Guided by professional practices and policies that are shaped by the role.

The role has moderate autonomy, requiring high levels of operational judgment.

Job Description Roles and Responsibilities Technical & Delivery Leadership Own software development execution within the team’s area of responsibility.

Lead design, development, verification, maintenance, and release activities for regulated software products.

Drive adoption of modern software engineering practices, including CI/CD, DevOps, test automation, observability, and engineering productivity improvements within the constraints of regulated development environments.

Establish and monitor engineering metrics related to quality, predictability, productivity, technical debt, and delivery performance.

Partner with architecture, systems engineering, and product leadership to define technical direction and execution strategy.

AI-Augmented Engineering Leadership Lead the responsible adoption of AI-enabled engineering practices across software development, testing, documentation, planning, and analysis.

Identify high-value opportunities where AI can improve engineering productivity, quality, consistency, and decision-making.

Establish repeatable AI-enabled workflows, templates, prompt libraries, and engineering practices that can be reused across teams.

Ensure AI-generated outputs are appropriately reviewed, validated, and governed before use in regulated product development activities.

Promote effective use of approved AI tools while maintaining compliance with company policies, security requirements, intellectual property protections, and regulatory expectations.

Track and communicate measurable improvements resulting from AI adoption, including cycle time, quality, automation, and engineering efficiency.

Drive an AI-first mindset while maintaining human accountability for engineering quality, safety, and business outcomes.

People & Organizational Leadership Lead, develop, and inspire a high-performing software engineering team.

Promote psychological safety, diversity, and inclusion within the team.

Provide coaching, mentoring, career development, and performance management; foster a culture of accountability, quality, innovation, collaboration, and continuous improvement.

Partner with HR and leadership on hiring, workforce planning, succession planning, and organizational development.

Coach team members and engineering leaders in the effective and responsible use of AI; promote sharing and reuse of successful practices and build capability for AI-augmented engineering.

Regulatory & Quality Compliance Ensure compliance with applicable medical device software regulations and standards, including IEC 62304, ISO 13485, MDR, and applicable FDA expectations.

Partner with Quality and Regulatory teams to support audits, inspections, and submissions.

Ensure software lifecycle documentation, including requirements, design, verification, validation, risk management, and traceability, is complete, accurate, and audit-ready.

Champion a quality-by-design mindset across software teams.

Ensure AI-enabled practices comply with applicable data privacy, cybersecurity, intellectual property, quality, and regulatory requirements.

Cross-Functional Collaboration Work with Program Management to define scope, milestones, risks, and dependencies.

Collaborate with Product Management and Systems Engineering to align technical execution with customer and business needs.

Communicate progress, risks, trade-offs, and recommendations clearly to senior leadership and stakeholders.

Support post-market activities, including incident investigation, root cause analysis, corrective actions, and continuous product improvement.

Required Qualifications Bachelor’s degree in an applicable technical or clinical field, such as Computer Science, Software Engineering, Engineering, or Clinical Informatics.

Minimum 15+ years of experience in the related field Demonstrated experience delivering regulated software, preferably for medical devices or other safety-critical systems.

Strong understanding of software development lifecycles, including Agile, hybrid, or V-model approaches in regulated environments.

Demonstrated experience leading teams through complex, multi-release products.

Excellent communication and influencing skills across functions and leadership levels.

Demonstrated applied experience using AI in software engineering or product-development workflows and driving responsible adoption