R+D Firmware Engineering Test Manager

JOB SUMMARY:

The R+D Firmware Engineering Testing Manager leads a team of firmware verification engineers to ensure the delivery of safe, effective, and high-quality embedded systems for medical devices. This role ensures robust test strategy development, execution, and regulatory compliance across new product development programs. The manager collaborates closely with cross-functional teams, drives continuous improvement in verification practices, and ensures traceability, documentation, and adherence to design controls under FDA and ISO regulations.

ESSENTIAL/PRIMARY DUTIES:

• Leads and mentors a team of firmware verification engineers through multiple development and V&V cycles.

• Defines and implements risk-based verification strategies across component, integration, and system levels.

• Establishes robust and scalable test methods for medical device firmware using both manual and automated approaches.

• Ensures verification and validation activities comply with FDA 21 CFR Part 820, ISO 13485, and IEC 62304.

• Collaborates with Systems Engineering and Quality Assurance to ensure test coverage and requirements traceability.

• Drives testing approach through HIL/SIL decisions and use of CI/CD frameworks.

• Implements and tracks quality metrics such as code coverage, regression stability, test effectiveness and defect escape rate.

• Lead fault injection, security‑related testing (e.g. secure boot, OTA update validation), and high‑assurance firmware test flows

• Develops and maintains test documentation including plans, protocols, and reports that are audit-ready.

• Oversees traceability matrix maintenance to ensure alignment with design inputs and risk mitigations.

• Drives investigation and root cause analysis for verification test failures and coordinates corrective actions.

• Supports continuous improvement of verification processes and test automation strategies aligned with medical device quality system requirements.

• Ensures appropriate test lab setup and execution processes for firmware and system-level verification.

SECONDARY DUTIES:

• Participates in risk management activities to support hazard analysis and FMEA.

• Evaluates and recommends test tools and platforms suitable for medical device V&V.

• Help define departmental roadmaps and forecast resource needs based on upcoming firmware deliverables

• Supports regulatory audits and inspections as a subject matter expert for verification.

• Other duties, as needed.

EDUCATION and/or EXPERIENCE:

• Bachelor’s or Master’s in Electrical/Computer Engineering, Computer Science or a related field.

• Minimum 8+ years firmware verification or validation experience, with at least 2+ years in an engineering management or technical leadership role.

• Experience in regulated environments (e.g., medical, safety‑critical) preferred.

COMPETENCY/SKILL REQUIREMENTS:

• Expert knowledge of medical device firmware/system verification methodologies

• Comprehensive understanding of FDA QSR, ISO 13485, and IEC 62304

• Strong experience with test protocol development, execution, and documentation

• Solid working knowledge of scripting or programming (Python, C/C++)

• Experience with automated test frameworks and tools appropriate for medical devices

• Skilled in creating traceability matrices and aligning test with risk controls

• Strong understanding of requirements management, defect tracking, and metrics analysis

• Excellent leadership, collaboration, and communication skills

• Familiarity with PLM and ERP systems (Agile, Oracle preferred)

• Knowledge of Lean or Agile principles within a regulated environment

SUPERVISORY RESPONSIBILITIES:

• Leads and directs the work of other teammates and typically has some authority for personnel decisions related to hiring, performance, or disciplinary actions.