R+D Firmware Engineering Test Manager

Midmark Corporation Career Opportunities•Versailles, OH

About The Position

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.

Requirements

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.
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

Nice To Haves

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

Responsibilities

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.
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.