Principal, R&D Engineer, Maintenance Release Tech Lead

About the role

In this role, you will provide end-to-end technical and project leadership for software maintenance releases supporting complex medical device systems. You will own maintenance releases from backlog and scope definition through development, release readiness, deployment and post-release transition, including strategic project decisions, the end-to-end integrated schedule and budget. Working across software, systems, quality, cybersecurity, regulatory and platform teams, you will ensure maintenance releases address field and product needs while maintaining a primary commitment to patient safety, product quality and compliance with Boston Scientific quality processes.

Your responsibilities will include

• Own the maintenance release end-to-end, including backlog, release scope, prioritization, strategic project decisions, execution, release readiness and transition to deployment.
• Maintain and prioritize the maintenance release backlog, incorporating field issues, product quality signals, cybersecurity needs, technical debt and other business or product inputs.
• Own strategic project decisions and technical tradeoffs; lead the technical assessment of proposed changes, define the release technical approach, and engage platform and functional subject matter experts for review and approval as required.
• Lead the cross-functional maintenance release team and drive alignment across systems, software, test, design assurance, cybersecurity, regulatory, DevOps, field service and other functions.
• Own the end-to-end integrated release schedule and budget, including milestones, dependencies, resource needs and tradeoffs required to deliver the release.
• Ensure the systems-owned overall verification and validation strategy and functional verification strategies are aligned with release scope, risk, schedule and release objectives.
• Own the maintenance release change control board process, including scope changes, strategic tradeoffs and coordination of defect and anomaly disposition.
• Proactively manage integrated project and technical risks and issues, drive resolution of cross-functional conflicts, and escalate significant risks or decisions to platform or franchise leadership as appropriate.
• Own the integrated release-readiness assessment and recommendation, ensuring required functional deliverables, reviews, approvals and objective evidence are complete before release.
• Effectively communicate release scope, strategic decisions, schedule, budget, risks, status and readiness to technical, functional and leadership stakeholders.

Required qualifications

• Bachelor's degree in software engineering, electrical engineering, biomedical engineering, systems engineering, computer science or a related technical field.
• Minimum of 7 years' experience developing and/or maintaining complex products in an engineering environment.
• Demonstrated ability to lead high-performing, cross-functional technical teams through complex product changes and technical problem-solving.
• Strong technical and systems-level understanding of complex software-enabled products and product architectures.
• Strong knowledge of medical device design controls, change control, risk management, cybersecurity, and verification and validation practices.
• Demonstrated ability to make technical tradeoffs, manage ambiguity and drive decisions.
• Excellent organizational, communication, collaboration and stakeholder management skills.
• Ability to effectively communicate technical risks, decisions and recommendations to senior leadership.
• Experience working across software, systems, cybersecurity, quality, regulatory, DevOps and field deployment functions.

Preferred qualifications

• Experience leading software maintenance releases or sustaining engineering for complex medical device systems.
• Medical device industry experience, including regulated software development and post-market product support.