Senior Designer – Design Verification & Validation

Job Overview

We are seeking an experienced Senior Designer Design Verification & Validation to support design verification, equipment qualification, documentation, and manufacturing process improvement activities in a medical device manufacturing environment. The ideal candidate will have experience with SolidWorks, Windchill, validation documentation, and cross-functional project support.

Key Responsibilities

• Support equipment qualification activities including IQ, OQ, and TMV.
• Create, update, and execute validation and test protocols.
• Develop and revise engineering drawings using SolidWorks.
• Manage document creation, updates, and release through Windchill.
• Support equipment software validation and prepare validation requirements.
• Create and maintain PFMEA, process instructions, and technical documentation.
• Perform GD&T drawing reviews and support design verification activities.
• Develop DOE (Design of Experiments) for process characterization.
• Create and release project deliverables, design specifications, and material specifications.
• Support manufacturing activities, supplier transfers, equipment repairs, and continuous process improvements.

Required Qualifications

• 5–8 years of experience in design verification, validation, or medical device product development.
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related discipline.
• Strong experience with SolidWorks and Windchill PLM.
• Hands-on experience with IQ/OQ/TMV, design verification, and validation documentation.
• Knowledge of GD&T, PFMEA, and DOE methodologies.
• Experience supporting manufacturing, engineering change documentation, and cross-functional projects.
• Strong technical documentation, problem-solving, and project management skills.

Preferred: Experience in a regulated medical device manufacturing environment.