Research and Development Test Engineer

Job Title: R&D Test Engineer

Duration: 12+ Month

Location: North Chicago, IL (Onsite)

Responsibilities

Develop and execute design verification strategies for medical devices and combination products.

Author verification plans, protocols, test reports, and related technical documentation aligned with regulatory and internal standards.

Determine appropriate sample sizes using statistical methods and perform detailed data analysis.

Write and execute engineering and verification test protocols and maintain accurate laboratory documentation, including electronic lab notebooks.

Present technical findings and results to cross-functional teams.

Lead technical investigations and perform root cause analysis for product or test failures.

Support CAPA activities and recommend risk mitigation strategies.

Define, develop, and validate test methods and support equipment qualification activities.

Maintain traceable documentation for testing and validation activities.

Recommend design and process improvements and review design changes for technical accuracy and compliance.

Ensure compliance with GLP, GMP, FDA, and ISO standards while following site safety and quality procedures.

Conduct materials characterization testing to evaluate physical and mechanical properties of materials used in product development and manufacturing.

Required Skill Sets

Bachelor’s degree in Engineering or related discipline (Mechanical or Biomedical Engineering preferred).

Minimum 3+ years of experience in medical devices or combination products.

Experience supporting or leading design verification activities in a regulated environment.

Knowledge of drug-delivery systems such as infusion devices, auto-injectors, or pre-filled syringes is preferred.

Familiarity with regulatory requirements including FDA QSR (21 CFR 820), GLP/GMP, ISO 13485, and ISO 14971.

Strong analytical, troubleshooting, and problem-solving skills.

Experience preparing technical documentation, verification protocols, and reports.

Strong written and verbal communication skills.