Design Verification Engineer (Lab Project Specialist) (Medical Devices)

Location: Chicago, Illinois, United States; work in a laboratory and/or clean room environment with PPE. Federal law requires eligibility to work in the United States.

Salary: $85,000–$115,000 USD per year.

Company

hirify.global is a global manufacturer of complex drug delivery systems and medical devices for the pharmaceutical industry, including inhalation, injection, nasal, dermal, and ophthalmic delivery products.

What you will do

• Develop and execute design verification strategies for new and existing medical devices.
• Review product requirements, design inputs, and risk analyses to define verification activities.
• Create verification protocols, test plans, acceptance criteria, and reports that provide objective evidence of compliance.
• Develop measurement systems, instrumentation, fixtures, data acquisition methods, and custom test equipment.
• Analyze test data, support root cause analysis, and recommend corrective actions.
• Coordinate with Design Engineering, Quality, Regulatory Affairs, laboratories, consultants, suppliers, and project teams.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Electrical, or Systems Engineering, or a related discipline.
• 3+ years of experience in medical device development, verification, testing, or systems engineering.
• Experience developing verification strategies, executing design verification programs, and developing test methods.
• Strong understanding of medical device design controls and product development processes.
• Experience analyzing data and preparing clear technical reports; strong technical writing and communication skills.
• Ability to independently assess designs and determine appropriate verification approaches, including work in a laboratory and/or clean room with PPE.

Nice to have

• Experience with inhalation, drug delivery, combination, surgical, diagnostic, or other complex medical devices.
• Knowledge of risk management and failure analysis methodologies.
• Experience with Minitab, JMP, or equivalent statistical analysis tools.
• Familiarity with IEC 60601, ISO 11608, or other applicable medical device standards.
• Experience managing external test laboratories and contract development partners.

Culture & Benefits

• Work in an international medical device manufacturing group focused on improving patient treatment adherence and outcomes.
• Collaborate across R&D, laboratory, Quality, Regulatory Affairs, and external partner functions.
• US employee benefits are available.
• hirify.global supports an equal opportunity workplace.