Lead Medical Device Verification Engineer — 6mo Contract

Ventura Solutions LLC; Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical and dental insurance

Paid vacation time

401(k) after 90 days

Job summary

Ventura Solutions is seeking an experienced Design Verification Engineer to lead planning, development, and execution of verification activities for medical device products in Chicago. You will translate requirements into robust test strategies and write detailed verification protocols and reports.

The role requires collaboration with R&D, Quality, Regulatory Affairs, and external partners, with emphasis on statistically analyzing test results, ensuring design controls, and mentoring junior

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering, or related discipline.
• 5+ years of experience in medical device development, verification, testing, or systems engineering.
• Demonstrated experience developing verification strategies and executing design verification programs.
• Strong understanding of medical device design controls and product development processes.
• Experience developing test methods and analyzing data.
• Excellent technical writing and communication skills.

Responsibilities

• Develop and execute design verification strategies for new and existing medical devices.
• Review product requirements, design inputs, and risk analyses to determine appropriate verification activities.
• Create verification protocols, test plans, acceptance criteria, and reports in compliance with applicable design control requirements.
• Ensure objective evidence is generated to demonstrate compliance with design requirements.
• Design, develop, optimize, and validate test methods for mechanical, functional, usability, environmental, reliability, and performance testing.
• Identify and implement appropriate measurement systems, instrumentation, fixtures, and data acquisition methods.
• Evaluate test method capability, repeatability, and reproducibility (e.g., GR&R).
• Develop custom test equipment and fixtures as needed.
• Support test method validation (TMV) and testing execution.
• Analyze test data using statistical and engineering methods.
• Support root cause analysis and recommend corrective actions.
• Prepare clear technical reports and present findings to project teams and management.
• Collaborate with Design Engineering, Quality, Regulatory Affairs, and Lab staff.
• Coordinate testing activities with external laboratories, consultants, and suppliers.
• Mentor junior engineers and provide leadership in verification and testing practices.
• Support overall project planning from a testing strategy perspective.
• Ensure verification activities comply with applicable standards, guidance documents, and internal procedures.
• Participate in Design Control, Risk Management, and Design History File (DHF) activities.
• Apply expertise in ISO 13485 and ISO 14971.

Skills

Design verification

Test planning

Statistical analysis

Technical writing

Independent assessment

Communication

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering, or related discipline

Tools

Minitab

JMP

Job description

Ventura Solutions is seeking an experienced Design Verification Engineer to lead planning, development, and execution of verification activities for medical device products in Chicago. You will translate requirements into robust test strategies and write detailed verification protocols and reports.

The role requires collaboration with R&D, Quality, Regulatory Affairs, and external partners, with emphasis on statistically analyzing test results, ensuring design controls, and mentoring junior