Cook Medical · 9 hours ago
Manager, Design Assurance
Bloomington, IN
Full-time
Onsite
Mid Level
3+ years expCook 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 teams, ensuring documentation compliance, and maintaining adherence to Cook Medical’s global quality systems and regulatory standards.
HardwareManufacturingMedical Device
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
Qualification
Required
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
Company
Cook Medical
Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group.
10001+ employees
H1B Sponsorship
Cook Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (3)
2022 (2)
Funding
Current Stage
Late StageLeadership Team
G
Gayle Cook
Co-founder
Kelly Fischer
Senior Vice President and Chief Financial Officer
Recent News
Company data provided by crunchbase