Cook Medical · 23 hours ago
Research and Development Engineer 2, Process Development
Bloomington IN United States
Full-time
Hybrid
Mid Level
3+ years expCook Medical is a company focused on developing innovative medical devices, and they are seeking a Process Development Engineer. The role involves designing and optimizing processes for manufacturing new medical devices while ensuring compliance with industry standards.
HardwareManufacturingMedical Device
Responsibilities
Collaborate in a team of engineers focused on design, development, and implementation of new processes and test methods (within Cook Medical facilities and/or with third party suppliers) required for the development and manufacture of new device designs
Execute methods needed for efficient and effective process and test method development (design for manufacturing/assembly, process validation, process capability, lean manufacturing, equipment selection and qualification, and specification development)
Ensure that a risk based approach is applied during the development, implementation, and validation of all processes and test methods
Responsible for process documentation (PFMEA’s, Validation Plans, Production Instructions, Drawings etc.) associated with new production processes
Liaise with new product introduction team and production engineering for process engineering layout plans and implementation in relation to new processes and production lines
Collaborate with R&D team, Operations, and Manufacturing Engineering to ensure the effective completion of all activities associated with transfer to manufacturing of an R&D engineering project / objective
Compare costs and benefits when determining manufacture of product in-house or supplier selection
Define, identify, procure, and qualify new equipment for manufacturing processes and test methods
Ability to complete projects within specific time lines, costs, 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
Qualification
Required
Minimum Bachelor's degree in Engineering or Engineering Technology
Strong knowledge of process validation, design for manufacturing, statistics, Design of Experiments (DOE), and lean manufacturing principles
Strong knowledge of medical device quality standards ISO13485/FDA practices, GMP and similar regulated industry standards
Proficient in Microsoft Office Software (Word, Excel, Visio, Power point, MS Project)
Ability to complete projects within specific time lines, costs, 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
Frequently required to sit, stand, walk, and communicate
Occasionally lifting with minimal exertion during shift
Ability to travel over-night up to 10% of time, if needed
Must be able to perform the essential functions of the job, with or without reasonable accommodations
Preferred
Preferred minimum 3 years experience working in Class II/III medical device manufacturing environment
Preferred knowledge of 3D Modeling software (Creo, Solid Works)
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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