RD Engineer Design Verification Validation Medical Devices

Job Description

Title: R &D Engineer (Design Verification & Validation)

Duration: 12+ Months - Very likely to be extended indefinitely

Location:

North Chicago, IL 60064

Onsite/Hybrid: Onsite laboratory environment (with cross-functional collaboration)

Client’s Combination Products / Medical Devices team is seeking an R&D Engineer to lead design verification and related test method development for drug-delivery systems (e.g., infusion devices, auto-injectors, pre-filled syringes). You’ll plan and execute verification activities, analyze data with scientific rigor, and drive root-cause investigations to enable safe, effective patient-centric products.

• Verification Leadership: Define, lead, and execute verification strategies; author verification plans, protocols, records, and reports aligned with internal procedures and regulatory expectations.
• Sampling & Statistics: Determine scientifically justified sample sizes consistent with internal policies and applicable regulations.
• Test Execution & Documentation: Write and execute engineering and verification test protocols; analyze results, maintain ELN/lab notebooks, and present findings to cross-functional teams.
• Root-Cause & CAPA Support: Lead issue investigations, document findings, and partner on resolutions and risk mitigations.
• Test Method Development: Define, develop, and validate test methods; qualify equipment and ensure traceable records.
• Design & Process Input: Recommend design and process improvements; review design changes for technical soundness and compliance.
• Compliance & Safety: Follow GLP/GMP, FDA/ISO requirements, and site safety policies; perform technical work to quality and functional standards.
• Materials Characterization: Conduct tests to determine physical/mechanical characteristics of materials for quality control, process control, and product development.

• Education: Bachelor’s degree in Engineering or a closely related discipline;
  Mechanical or Biomedical Engineering preferred.
• Experience: 3+ years in medical devices or combination products (ideally infusion devices, auto-injectors, pre-filled syringes). 5–7 years leading design verification activities in a regulated environment.
• Technical Depth: Demonstrated problem-solving skills with strong analytical approach and documentation discipline.
• Regulatory Knowledge: Working knowledge of GLP, GMP, FDA QSR (21 CFR 820) and relevant standards (e.g., ISO 13485/14971).
• Communication: Clear written and verbal communication; ability to present technical results to diverse stakeholders.

• Lab & Measurement Systems: Zwick/Instron mechanical testers; flow measurement equipment; viscometers; climate chambers; 3D printing exposure.
• Engineering & Analysis: Solid Works, Minitab; fundamentals of statistics and Six Sigma techniques.
• Lifecycle & Traceability: Microsoft Project; LIMS (e.g., LinkUS);
  Requirements/Risk tools (e.g., DOORS, Cockpit);
  Electronic Lab Notebook (ELN).
• Systems Mindset: Experience with electro-mechanical systems and system-level verification of combination products.

• Self-driven, organized, and detail-oriented with a commitment to accuracy.
• Comfortable working independently with guidance from a supervisor/technical lead.
• Effective collaborator in a matrixed, cross-functional environment.

Assignments have clear, defined objectives. You’ll own verification deliverables end-to-end—planning, execution, analysis, documentation—and contribute to design improvements and risk reduction for patient-facing drug-delivery products.

R&D Engineer (DV&V) — 12-month contract | North Chicago, IL
Lead design verification for client drug-delivery devices. Own protocols, test method development, data analysis, and root-cause investigations in a regulated environment. Must have: 3+ yrs medical devices/combination products; 5–7 yrs verification leadership; GLP/GMP/FDA knowledge. Tools:
Zwick/Instron, Solid Works, Minitab, LIMS/ELN, DOORS