Cook Medical · 2 weeks ago
New Product Introduction Engineer 2
Bloomington, IN
Full-time
Onsite
Mid Level
3+ years expCook Medical is seeking a New Product Introduction Engineer to bridge Product Development into Manufacturing Engineering, Quality, and Operations. The role involves configuring and optimizing processes for manufacturing new medical devices and evaluating processing options based on product attributes.
HardwareManufacturingMedical Device
Responsibilities
Collaborate in a team of engineers focused on design, development, and implementation of new processes (within Cook Inc Facilities) required for the manufacture of new device designs
Execute methods needed for compliant, efficient and effective process development (design for manufacturing, process validation, process capability, lean manufacturing, equipment selection and specification development)
Utilize and apply a risk based approach during the development, implementation, and validation of all processes
Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with new products
Collaborate with R&D team, Operations, and Production engineering to ensure the effective completion of all activities associated with transfer to manufacturing of an R&D Engineering project / objective
Advice new product development team on making vs. buying decisions for components
Define, identify, and procure new equipment for manufacturing processes
Ability to complete projects within specific time lines and meeting performance expectations
Must work and interact effectively and professionally with and for others throughout various levels of the global organization
Maintain regular and punctual attendance
Must have effective oral, written and presentation communication skills
Ability to work in collaborative and independent work situations and environments with minimal supervision
Represent Operations Principles of the Cook Operating System
Champion line start up, support, and training
Promote and driven integrated manufacturing, driving quality at source
Qualification
Required
Bachelor's degree in Engineering, or Engineering Technology
Minimum of 3 years experience working in Class II/III medical device manufacturing environment with qualification of new processes and equipment validation
Knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles
Knowledge of medical device quality standards ISO13485/FDA practices, GMP and similar regulated industry standards
Experience using analytic skills and problem solving
Working knowledge of Microsoft Office Software (ie Word, Excel, Visio, Power point, MS Project)
Ability to complete projects within specific time lines and meeting performance expectations
Must work and interact effectively and professionally with and for others throughout various levels of the global organization
Maintain regular and punctual attendance
Must have effective oral, written and presentation communication skills
Ability to work in collaborative and independent work situations and environments with minimal supervision
Represent Operations Principles of the Cook Operating System
Champion line start up, support, and training
Promote and driven integrated manufacturing, driving quality at source
Preferred
Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc)
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
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