MGC Diagnostics · 22 hours ago
Test Engineer III
Twin Cities Area
Full-time
Onsite
Mid, Senior Level
3+ years expMGC Diagnostics is a company focused on regulated medical devices, and they are seeking a Test Engineer III to lead verification and validation activities. This role involves planning and executing tests, ensuring compliance with regulatory standards, and collaborating with cross-functional teams throughout the product development lifecycle.
Health CareHealth DiagnosticsMedicalMedical Device
Hiring Manager
Jordan Ochoa
Responsibilities
Conduct pre-verification testing prior to formal verification and validation protocol execution
Develop, author, and execute formal verification and validation protocols for medical devices, including capital equipment, handheld devices, and sensors/disposables
Perform hands-on testing across multiple domains, including: Electrical safety, Flow and pressure performance, Gas delivery and sensing, End-product and simulator-based testing
Ensure testing is conducted in accordance with approved protocols, standards, and internal procedures
Author clear, complete, and compliant test documentation, including protocols, reports, and supporting evidence suitable for regulatory submissions
Ensure test activities align with applicable standards and regulations (e.g., ISO 13485, ISO 14971, IEC 60601, IEC 62304 where applicable)
Support regulatory submissions by providing high-quality test documentation and traceable objective evidence
Work closely with Systems Engineering to ensure test coverage of system- and subsystem-level requirements and interfaces
Participate in design reviews, risk management activities, and testability reviews to influence product quality upstream
Collaborate with Hardware Engineering on defect investigation, root cause analysis, and verification of corrective actions
Cross-training with Software QA Team and assist with software-related testing as needed
Interface with QARA to ensure test strategies and documentation meet compliance expectations
Act as a test lead on development projects, coordinating and guiding execution by technicians and junior engineers
Informally direct test resources during protocol execution while maintaining accountability for results and documentation quality
Utilize existing test fixtures and equipment; contribute to the specification, design, or improvement of new fixtures as needed
Maintain ownership of assigned lab spaces, ensuring equipment readiness, organization, and compliance with safety and quality requirements
Identify opportunities to improve test efficiency, robustness, and repeatability
Introduce automation where appropriate to supplement manual testing
Contribute to the evolution of test methods, templates, and best practices across the organization
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline)
3–6 years of experience in test, verification, or validation engineering within a regulated industry (medical devices strongly preferred)
Hands-on experience with hardware testing and laboratory-based test execution
Experience authoring formal test protocols and reports in a quality-managed environment
Working knowledge of medical device development processes and lifecycle controls
Strong attention to detail, documentation quality, and data integrity
Methodical, analytical approach to problem solving
Comfortable working hands-on in a lab environment
Able to balance execution speed with regulatory rigor
Strong written and verbal communication skills
Demonstrated ability to lead test activities and influence cross-functional teams without formal authority
Motivated to grow into a senior technical role with broader ownership and influence
Preferred
Experience testing integrated systems involving hardware, firmware, and software
Familiarity with electrical safety testing and use of common lab instrumentation
Experience with fixture design, specification, or hands-on build support
Exposure to risk management activities and design control processes
Experience supporting regulatory submissions (FDA, EU MDR, or equivalent)
Company
MGC Diagnostics
MGC Diagnostics develops non-invasive diagnostic systems for detecting and managing cardiorespiratory disease.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2022-11-29Acquired
2003-01-17IPO
Leadership Team
Lew Schildkraut
Chief Financial Officer
Recent News
Research and Markets
2025-04-08
Company data provided by crunchbase