Design Engineer – Medical Device

Design Engineer – Medical Device (Contract)

Location: Richmond, IL
Duration: 6-Month Contract (July 2026 – December 2026)
Schedule: Full-Time, 40 Hours/Week, Monday–Friday Day Shift
Department: Manufacturing Science & Engineering

We are seeking a Design Engineer to support a medical device organization through a critical New Product Development (NPD) initiative and Design History File (DHF) remediation activities. This role combines technical design engineering responsibilities with project leadership, requiring close collaboration with cross-functional teams across multiple global sites.

The successful candidate will be responsible for driving project execution, coordinating validation activities, and authoring key design control documentation in a regulated environment.

• Facilitate weekly project meetings and coordinate activities between global sites.
• Track project timelines, risks, and deliverables to ensure successful execution.
• Coordinate on-site activities related to verification and validation (V&V), process validation, and equipment installations.
• Author, review, and maintain Design History File (DHF) documentation.
• Develop and maintain product requirements, specifications, and design documentation.
• Support risk management activities and maintain associated documentation.
• Create and review verification and validation protocols and reports.
• Apply statistical analysis techniques and Design of Experiments (DOE) methodologies to support product development and process improvement initiatives.
• Ensure compliance with applicable design control requirements and quality system standards.

• Support activities within a regulated medical device environment.
• Ensure documentation is complete, accurate, and audit-ready.
• Adhere to quality system requirements and established engineering processes.
• Collaborate with quality, manufacturing, and regulatory teams to support project objectives.

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 2 years of experience in a regulated industry with design control requirements.
• Strong technical writing and documentation skills.
• Proficiency with Microsoft Office applications.
• Excellent communication, organization, and project coordination skills.

• Experience in the medical device industry.
• Familiarity with Design History Files (DHF), risk management documentation, and design verification activities.
• Knowledge of statistical analysis and Design of Experiments (DOE).
• Understanding of quality systems and regulatory standards such as ISO 9001 and ISO 13485.
• Experience working with cross-functional and global project teams.
• Project Management
• Medical Device Design Controls
• Design History Files (DHF)
• Verification & Validation (V&V)
• Technical Documentation
• Statistical Analysis
• Design of Experiments (DOE)
• Cross-Functional Collaboration
• Problem Solving
• Communication & Organization

Success will be measured by:

• Delivery of complete, accurate, and compliant engineering documentation.
• Effective coordination of project activities and stakeholders.
• Support of program timelines without preventable delays or rework.
• Consistent reliability, professionalism, and adherence to safety and quality requirements.