Design Control Engineer

We are seeking an experienced Design Control Engineer to support product development, engineering design changes, and new product releases within a regulated Medical Device environment. The ideal candidate will have a strong Mechanical Engineering background, hands-on experience with design control processes, product lifecycle management (PLM), verification & validation (V&V), and technical documentation while ensuring compliance with Quality Management System (QMS) and applicable regulatory standards.

• Execute and support design control activities throughout the product development lifecycle.
• Manage engineering design changes and support new product releases.
• Update and maintain CAD drawings, engineering documentation, and PLM records.
• Develop, execute, and document Verification & Validation (V&V) protocols and testing activities.
• Perform hands-on product testing and analyze test results.
• Prepare technical reports, test summaries, and engineering documentation.
• Interpret engineering drawings and specifications to support product development and testing.
• Route engineering documents through review and approval workflows.
• Maintain Design History Files (DHF), Device Master Records (DMR), and other design documentation.
• Ensure compliance with Quality Management System (QMS), FDA regulations, and applicable industry standards.
• Collaborate with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs.
• Support risk management, design verification, and product validation activities throughout the development process.

• Bachelor's degree in Mechanical Engineering or a related Engineering discipline.
• 5+ years of Design Control experience within the Medical Device industry.
• Strong understanding of Medical Device product development processes.
• Experience managing engineering design changes and new product releases.
• Hands-on experience with Product Lifecycle Management (PLM) systems.
• Experience with CAD tools and engineering drawing updates.
• Strong knowledge of Design Verification & Validation (V&V).
• Experience performing hands-on product testing and documenting results.
• Strong technical writing, protocol development, and report writing skills.
• Experience working within Quality Management Systems (QMS).
• Excellent analytical, documentation, and communication skills.