Manager, Design Assurance
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
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 Medicals 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 Medicals 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 Medicals 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
- Bachelors 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.
Required Experience:
Manager
Key Skills
- Haskell
- Construction Experience
- Management Experience
- Autodesk
- Design Thinking
- Library Services
- Drafting
- Project Management
- Relationship Management
- Adobe Photoshop
- Autocad
- Child Protective Services
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
