Design Assurance Engineer 2

About the role

Design Assurance Engineer 2 will provide design assurance support for new product development by ensuring that design controls, verification and validation, risk management, regulatory compliance, and product change activities are effectively implemented and maintained.

Responsibilities

• Provide design assurance support for new product development and on-market medical devices.
• Facilitate application of design controls throughout product development and sustaining product activities.
• Support manufacturing-related design changes, regulatory compliance, manufacturability improvements, and cost-reduction evaluations.
• Participate in new product development projects by ensuring product inputs are clearly defined and that design verification and validation activities confirm requirements are met.
• Support test method validation as part of verification and validation activities.
• Participate in sustaining product projects by ensuring projects are well-defined, remain on task, and include required verification, validation, and risk management activities.
• Collaborate with R&D to coordinate design elements of Risk Management files and ensure compliance with applicable standards and internal policies.
• Coordinate Health Risk Assessment activities for on-market products, with manager or lead support as needed.
• Analyze product issues efficiently, including defining problems and evaluating potential impact.
• Assess product change requests for design impact and determine required supporting documentation for implementation.