Midmark Corporation · 3 weeks ago
R+D Firmware Engineering Test Manager
Versailles, OH
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expMidmark Corporation is a company focused on delivering safe and effective medical devices, and they are seeking an R+D Firmware Engineering Test Manager to lead a team of firmware verification engineers. This role is responsible for developing robust test strategies, ensuring regulatory compliance, and driving continuous improvement in verification practices.
Health CareManufacturingMedical Device
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
Qualification
Required
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
Preferred
Experience in regulated environments (e.g., medical, safety‑critical)
Familiarity with PLM and ERP systems (Agile, Oracle preferred)
Knowledge of Lean or Agile principles within a regulated environment
Company
Midmark Corporation
Midmark Corp manufactures and supplies medical, dental, and animal health products.
1001-5000 employees
H1B Sponsorship
Midmark Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (1)
2022 (2)
2021 (4)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Susan Martin
Vice President & Midmark RTLS
Recent News
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