R+D Firmware Engineering Test Manager

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.

• Job Identification 4251
• Job Category Engineering
• Posting Date 12/22/2025, 10:38 PM
• Job Schedule Full time
• Locations 60 Vista Dr, Versailles, OH, 45380, US