Lead Software Development Engineer in Test

The Position Gen Mark Diagnostics is seeking a Lead SDET to architect the next generation of our automated verification strategy. This is a high‑impact "Player‑Coach" role where you will balance hands‑on framework development with the leadership of a dedicated team of Software Quality Engineers.

• Technical Debt Remediation:
  Act as the specialist in reducing our manual testing burden. Identify and automate "High‑Value/Low‑Effort" manual tests first to rapidly buy the team breathing room and accelerate feedback cycles.
• Framework Design:
  Architect and build scalable, maintainable test automation frameworks (using C#, Selenium, Appium, or similar) to support both UI and backend logic, utilizing advanced object‑oriented programming.
• Hardware & Integration Testing:
  Design test strategies that account for hardware‑in‑the‑loop (HiL) testing and software interactions with physical diagnostic instruments and sensors.
• Continuous Integration & Security:
  Partner with the Dev Ops/Architecture team to integrate automated suites into Azure Dev Ops pipelines. Lead the automation of vulnerability scanning and static/dynamic analysis (SAST/DAST) to align with modern FDA cybersecurity guidelines.
• Tooling Selection:
  Evaluate and select the right tools for performance profiling, load testing, and security scanning to ensure comprehensive coverage.

• Technical Mentorship:
  Act as the technical anchor for the SW Quality team. Mentor Quality Engineers on coding best practices, automation scripting, and source control management.
• Team Growth:
  Foster a collaborative environment where manual testing expertise is complemented by growing technical skills. Lead code reviews for test scripts to ensure they meet production‑quality standards.
• Resource Management:
  Balance hands‑on coding (the "Player") with team leadership (the "Coach"). Align team activities with the software roadmap, ensuring that verification activities happen in parallel with development rather than lagging behind.

• Tool Validation:
  Collaborate closely with Regulatory Affairs (RA) to formally validate automated testing tools, ensuring they meet strict regulatory compliance standards.
• V&V Modernization:
  Enhance Master V&V Plans to support automated evidence generation, ensuring strict compliance with FDA 21 CFR Part 820 and ISO 13485 standards.
• Metrics Driven:
  Define and track key quality metrics (e.g., Defect Density, Automation Coverage) to drive continuous improvement and transparency.
• Risk Analysis:
  Participate in software hazard analysis (FMEA) to ensure safety‑critical workflows are prioritized in the automation strategy.

• Education and Experience:
  
  Bachelor’s Degree in Computer Science, Computer Engineering, or related technical discipline. 8+ years of software engineering or SDET experience (must have hands‑on coding experience). 3+ years of leadership experience (Team Lead or Manager). Experience transforming a manual testing team into an automation‑first team is highly preferred.

• Strong Coding Ability:
  Deep proficiency in C#/.NET. Must be able to write production‑quality code and demonstrate an understanding of advanced concepts (e.g., async/await, modern .NET core, RESTful API integration, and mocking frameworks like Moq).
• Framework
  
  Experience:
  
  Proven experience building automation frameworks from scratch (e.g., Selenium Web Driver, Appium for UI, NUnit/xUnit for API/Logic).
• Methodology:
  Explicit experience implementing Test Driven Development (TDD) or Behavior Driven Development (BDD, e.g., Spec Flow) to align engineering and quality teams.
• Hardware Integration:
  Experience with hardware‑in‑the‑loop (HiL) testing or testing against physical sensors is highly preferred.
• CI/CD Ops:
  Experience configuring build pipelines in tools like Azure Dev Ops, Jenkins, or Git Hub Actions.
• Regulated Environment:
  Experience working in an FDA‑regulated environment is a strong plus.

• Change Agent: A passion for modernizing workflows and showing teams "the art of the possible" with automation.
• Collaborative:
  Ability to work closely…