Research and Development Engineer 2, Process Development
Cook Group
full-time
Posted on:
Location Type: Office
Location: Bloomington • United States
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Tech Stack
About the role
- Collaborate in a team of engineers focused on design, development, and implementation of new processes and test methods 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.
Requirements
- Minimum Bachelor's degree in Engineering or Engineering Technology
- Preferred minimum 3 years experience working in Class II/III medical device manufacturing environment
- 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)
- Preferred knowledge of 3D Modeling software (Creo, Solid Works)
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
process validationdesign for manufacturinglean manufacturingDesign of Experiments (DOE)process capabilityequipment selectionspecification developmentrisk management
Soft Skills
collaborationcommunicationproject managementproblem-solvingtime management
Certifications
Bachelor's degree in EngineeringISO13485 certificationGMP certification