Principal Engineer, Software Development Excellence

Hologic•Newark, DE

About The Position

The Principal Engineer provides technical leadership to advance software engineering excellence for software‑centric Class II medical device products. This role defines and scales best practices, frameworks, patterns, and standards that future teams will use, enabling high‑quality, compliant development within FDA‑regulated and IEC 62304‑aligned environments. Working in a cross‑functional, matrixed organization, this role partners with software, systems, hardware, quality, regulatory, and product teams to ensure development practices support patient safety, fault tolerance, maintainability, and long‑term product quality. By championing modern, right‑sized practices and tools, the Principal Engineer sets the standard for how the organization builds safe, reliable, and innovative products.

Responsibilities

Define, document, and evolve software development best practices, templates, and workflows aligned with IEC 62304 and applicable FDA guidance.
Ensure architectural principles are reflected in everyday development practices through close collaboration with software architects and senior engineers.
Promote frameworks, tools, and processes that enhance patient safety, fault tolerance, robustness, and maintainability.
Design and scale Agile practices that balance iterative delivery with design controls and verification needs.
Drive effective use of tools (e.g., Jira, Azure DevOps, GitHub) for planning, traceability, reviews, and controlled change.
Define and track engineering and Agile metrics (e.g., velocity, cycle time, lead time, defect trends) to inform decisions.
Use metrics to identify bottlenecks, reduce risk, and continuously improve predictability and quality.
Coach engineers and technical leads on Agile methods, Git workflows, and DevOps pipelines with appropriate quality controls.
Partner with cross‑functional teams to translate safety, risk, and system requirements into practical engineering workflows.