Control Design Engineer

Role : Design Control V&V Consultant

Remote

Contract : 6 Months

Role Overview :

We are seeking a highly skilled and experienced Design Control Verification & Validation (V&V) Consultant with a focus on clinical validation for a critical project with a global medical device client.

The consultant will be responsible for conducting gap assessments, process improvement, and developing robust validation strategies, especially for implantable devices and electro-mechanical systems, some of which involve AI-driven components.

This role is integral to improving design controls and ensuring compliance with FDA requirements, particularly in light of recent post-market observations.

Key Responsibilities :

Lead and execute design verification and validation activities with a focus on clinical validation of medical devices, particularly implants and electro-mechanical devices.

Perform gap assessments and identify process improvements within the design control framework, ensuring alignment with FDA 483 observations.

Develop, document, and implement design control procedures and validation strategies across the product lifecycle, from design through clinical validation and market release.

Ensure clinical validation aligns with regulatory requirements and industry best practices, including proper statistical methods, study models, and procedures.

Collaborate with cross-functional teams (including R&D, Quality, Regulatory, and Clinical) to ensure design validation activities are conducted effectively and efficiently.

Provide guidance on AI-driven devices, focusing on how to structure validation protocols to meet regulatory scrutiny.

Create training programs and provide coaching to internal teams on design control and validation processes.

Act as a liaison between clinical teams, regulatory bodies, and management to ensure thorough documentation and adherence to compliance.

Required Qualifications :

Bachelor’s degree or higher in engineering, biomedical engineering, or a related field. Advanced degree preferred.

10+ years of experience in the medical device industry with deep expertise in design control and V&V.

Extensive knowledge and practical experience in clinical validation, especially for implantable medical devices and electro-mechanical systems.

Proven track record of successful validation projects in compliance with FDA regulations, including handling FDA observations such as 483s.

Strong understanding of risk management, statistical methods, and the use of validation models in clinical settings.

Familiarity with AI components in medical devices and their impact on design and validation processes is a plus.

Ability to work independently and in a cross-functional team, including close collaboration with clinical, regulatory, quality, and R&D departments.

Preferred Skills :

Previous experience with FDA-experienced teams or ex-FDA professionals is highly desired.

Ability to draft clear, concise procedures, validation protocols, and documentation.

Strong project management and leadership skills, with a focus on practical execution and tangible results.

Knowledge of software tools related to design control and risk management (e.g., JIRA, PLM systems) and advanced technology solutions for design control.