R&D Engineer (Design Verification & Validation)

Job Title: R&D Engineer (Design Verification & Validation)
Location: Illinois (Onsite)
Employment Type: Contract (12 Months, Potential Extension)

Overview:
Seeking an experienced R&D Engineer to support design verification and validation activities for medical device and combination product development. This role will focus on verification strategy, test method development, data analysis, root cause investigations, and regulatory compliance within a regulated product development environment.

Required Qualifications:
Bachelor's degree in Engineering, Mechanical Engineering, Biomedical Engineering, or related field
3+ years of experience in Medical Devices or Combination Products
Design Verification & Validation experience in a regulated environment
Experience authoring and executing verification protocols, reports, and test methods
Knowledge of GLP, GMP, FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971
Strong analytical, problem-solving, and technical documentation skills
Experience with statistical analysis and sample size justification

Key Responsibilities:
Lead design verification planning, execution, and reporting activities
Develop, validate, and maintain test methods and associated documentation
Execute engineering and verification testing, analyze data, and present findings
Conduct root cause investigations and support corrective actions
Review design changes and recommend product/process improvements
Support equipment qualification and ensure traceable laboratory records
Perform materials characterization and product performance testing
Collaborate with cross-functional teams to ensure compliance and project success

Preferred Qualifications:
Experience with infusion devices, auto-injectors, or pre-filled syringe systems
Hands-on experience with Zwick/Instron testing equipment, climate chambers, and flow measurement systems
Proficiency with SolidWorks, Minitab, LIMS, ELN, DOORS, and Microsoft Project
Knowledge of electro-mechanical systems and system-level verification
Exposure to Six Sigma methodologies and statistical analysis tools
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