Manager, Design Assurance

Location: Bloomington, IN, US

Employment Type: FULL_TIME

Overview

Cook Medical is seeking a dedicated and experienced Manager of Design Assurance to lead our Design Assurance team within the Quality Assurance department. This key leadership role involves guiding new product development (NPD) teams, ensuring documentation compliance, and maintaining adherence to Cook Medical’s global quality systems and regulatory standards.

Responsibilities

• Lead and manage the Design Assurance Engineering team, including workload management, coaching, and development of team members.
• Act as a liaison with company leadership, representing Design Assurance interests.
• Provide guidance and mentorship to NPD teams on Cook Medical’s global Design Controls, Process Development, and Risk Management policies and systems.
• Participate directly in new product development projects, contributing to design reviews and project deliverables.
• Drive the development, deployment, and training of global Design Controls, Process Development, and Risk Management policies.
• Maintain a comprehensive understanding of Cook Medical’s design and development policies, standards, and applicable regulations.
• Ensure all quality, regulatory, compliance, and product-specific requirements are met within scope.
• Foster employee growth through mentorship, training, and feedback.
• Collaborate with HR on recruiting and hiring efforts.
• Establish and monitor team goals to meet quality assurance objectives.

Qualifications

• Bachelor’s Degree in Engineering (Mechanical, Chemical, Manufacturing, Biomedical preferred).
• Minimum of 3 years’ experience in R&D, new product/process development, or quality assurance/engineering.
• Broad knowledge of Design Controls, Process Development, and Risk Management systems.
• Strong communication, problem-solving, and collaboration skills.
• Ability to work independently and in team environments.

Physical & Travel Requirements:

• Mainly office-based work with occasional domestic/international travel supporting project activities.
• Flexibility to communicate outside of regular hours as needed.