Project Manager

Senior Design Assurance Engineer

Our client, a leading organization in the medical device industry, is seeking a Senior Design Assurance Engineer to join their team. As a Senior Design Assurance Engineer, you will be part of the Quality Department supporting cross-functional teams including R&D, Regulatory, Manufacturing Engineering, and Quality Engineering. The ideal candidate will have strong analytical skills, attention to detail, and the ability to collaborate effectively, which will align successfully within the organization.

Job Title: Senior Design Assurance Engineer Location: MA, Marlborough Pay Range: $55 $70 per hour (based on experience)

What's the Job?

• Provide design assurance support for new product development and existing medical devices.
• Facilitate the application of design controls to ensure regulatory compliance and product quality.
• Conduct independent reviews and audits of Design History Files (DHF) and related documentation.
• Collaborate with R&D and other teams to maintain risk management files and ensure compliance with applicable standards.
• Evaluate and support design and process changes, ensuring verification and validation requirements are met.

What's Needed?

• Bachelor's degree in a technical field.
• 25 years of experience, preferably within the medical device industry.
• Knowledge of FDA Quality System Regulations, ISO 13485, and Design Control requirements.
• Familiarity with ISO 14971 (Risk Management) and related medical device standards.
• Strong understanding of verification and validation processes for regulated products.

What's in it for me?

• Medical insurance
• Dental insurance
• Disability insurance
• Life insurance
• Weekly payment

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity.