Design Verification Engineer

Our client is seeking an experienced Design Verification Engineer to lead the planning development and execution of verification activities for medical device products. This individual will serve as a technical expert in device testing design inputs risk analyses and translating product requirements into robust verification strategies and test methods.

The ideal candidate possesses a strong engineering background understands how medical devices function from both a design and user perspective and can independently determine what testing is required to demonstrate that design requirements have been met. This role works closely with R&D Lab Quality Regulatory Affairs and external partners throughout the product development lifecycle.

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.

Qualifications

• Bachelors 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.
• Ability to independently assess designs and determine appropriate verification approaches.
• Experience with inhalation drug delivery combination products surgical diagnostic or other complex medical devices is a plus.
• Knowledge of risk management and failure analysis methodologies is a plus.
• Experience with statistical analysis tools such as Minitab JMP or equivalent is a plus.
• Familiarity with IEC 60601 ISO 11608 or other applicable medical device standards is a plus.
• Experience managing external test laboratories and contract development partners is a plus.

Location

• Chicago IL

Employee Type

• W2 Contract (approximately 6 months)
• Potential for contract-to-hire conversion

Compensation & Benefits

• Hourly rate $45-$55
• Medical and dental insurance
• Paid vacation time
• 401(k) after 90 days

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting staffing and training firm. With our deep industry expertise spanning medical devices and combination products coupled with an outstanding talent pool we stand out as the preferred option for a diverse array of projects. On the consulting side we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side we help source screen and on-board reputable employees to fill temporary temp to permanent and permanent job openings. We accelerate product development keep products compliant and help build great organizations. For more information visit us at .

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Required Experience:

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