Staff Design Quality Engineer
About The Position
The Staff Design Quality Engineer is an experienced technical individual contributor responsible for ensuring the safety, effectiveness, and compliance of medical devices throughout the design and development lifecycle. This position provides technical expertise in implementing and maintaining quality management system requirements, leading design control and risk management activities for product development projects, and supporting the execution of quality and business objectives established by leadership. The Staff DQE collaborates with internal and external cross-functional teams to deliver high-quality medical device solutions that meet regulatory, customer, and business requirements. This position serves as a key quality representative on product development and sustaining engineering projects, providing guidance on quality engineering principles, design controls, risk management, verification and validation activities, and supplier quality processes. The Staff DQE influences project-level quality decisions, drives compliance to applicable standards and regulations, and supports continuous improvement initiatives within the organization. The Staff Design Quality Engineer provides technical leadership and quality engineering support to ensure the successful development, transfer, and ongoing support of Cooper products. This individual applies knowledge of design controls, risk management, verification and validation principles, quality engineering techniques, and supplier quality processes, including supplier collaboration and PPAP execution, to ensure safe and effective products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer expectations. The Staff Design Quality Engineer provides guidance on scientific and technical data related to product design, manufacturing processes, and product testing to support quality and compliance objectives. This position partners cross-functionally with R&D, Operations, Regulatory, Supplier Quality and Clinical teams. The Staff DQE provides guidance and knowledge sharing to peers and less experienced engineers, contributes to problem-solving activities and continuous improvement efforts, and supports the successful execution of product development and sustaining engineering programs.
Requirements
- Experienced technical individual contributor
- Knowledge of design controls
- Knowledge of risk management
- Knowledge of verification and validation principles
- Knowledge of quality engineering techniques
- Knowledge of supplier quality processes, including supplier collaboration and PPAP execution
- Ability to provide guidance on scientific and technical data related to product design, manufacturing processes, and product testing
- Ability to partner cross-functionally with R&D, Operations, Regulatory, Supplier Quality and Clinical teams
- Ability to provide guidance and knowledge sharing to peers and less experienced engineers
- Ability to contribute to problem-solving activities and continuous improvement efforts
Responsibilities
- Ensuring the safety, effectiveness, and compliance of medical devices throughout the design and development lifecycle.
- Implementing and maintaining quality management system requirements.
- Leading design control and risk management activities for product development projects.
- Supporting the execution of quality and business objectives established by leadership.
- Collaborating with internal and external cross-functional teams to deliver high-quality medical device solutions that meet regulatory, customer, and business requirements.
- Serving as a key quality representative on product development and sustaining engineering projects.
- Providing guidance on quality engineering principles, design controls, risk management, verification and validation activities, and supplier quality processes.
- Influencing project-level quality decisions.
- Driving compliance to applicable standards and regulations.
- Supporting continuous improvement initiatives within the organization.
- Providing technical leadership and quality engineering support to ensure the successful development, transfer, and ongoing support of Cooper products.
- Applying knowledge of design controls, risk management, verification and validation principles, quality engineering techniques, and supplier quality processes, including supplier collaboration and PPAP execution.
- Ensuring safe and effective products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer expectations.
- Providing guidance on scientific and technical data related to product design, manufacturing processes, and product testing to support quality and compliance objectives.
- Partnering cross-functionally with R&D, Operations, Regulatory, Supplier Quality and Clinical teams.
- Providing guidance and knowledge sharing to peers and less experienced engineers.
- Contributing to problem-solving activities and continuous improvement efforts.
- Supporting the successful execution of product development and sustaining engineering programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
