Design Quality Engineer II

CooperSurgical, Inc.; Trumbull (CT); On-site; USD 85,000 - 120,000; Full time

Job summary

CooperSurgical, Inc. seeks a Design Quality Engineer II to support design quality engineering during development and lifecycle operations of medical devices.

The role emphasizes fertility solutions products and risk management, applying design control principles and quality engineering methods to ensure compliance with regulatory requirements and customer expectations. The candidate collaborates with cross-functional teams, reviews technical data, and contributes to ongoing product and process

Qualifications

• Experience applying design control principles in medical device development.
• Knowledge of regulatory requirements for medical devices and quality systems.
• Ability to review scientific data and testing results to support product development.

Responsibilities

• Provide design quality engineering support to ensure successful development and ongoing operation of Cooper products.
• Review and evaluate data related to product development and testing, contributing to problem solving for product and process improvements.
• Collaborate with cross-functional teams and provide guidance on quality engineering activities, design controls, and risk management.

Skills

Design controls

Quality engineering

Regulatory compliance

Cross-functional collaboration

Job description

The Design Quality Engineer II provides Design Quality Engineering support to ensure the successful development of Cooper products and ongoing operational support, applying knowledge of design control principles and quality engineering techniques to support development efforts and address quality-related challenges. This role is responsible for ensuring products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer expectations, and reviews and evaluates scientific and technical data related to product development and testing, contributing to problem-solving activities for product and process improvements, while collaborating with cross-functional teams and providing guidance when appropriate.

The Design Quality Engineer II supports the safety, effectiveness, and compliance of medical devices throughout the design and development lifecycle. This position contributes to maintaining quality management systems, supporting design control activities, and collaborating with cross-functional teams to deliver high-quality medical products. This role will specialize in fertility solutions products and risk management.