Basic Background Requirements
This position will require
Enrolled in a 4-year degree program in Engineering or Engineering Technology (Mechanical, Electrical, Biomedical)
3 months to 3 years’ relevant intern work experience with knowledge of a variety of production methods and materials preferred
Validation experience, process and equipment qualification (IQ, OQ, PQ), Test Methods & R&R’s
Process development/characterization experience
Ability to analyze data using statistical methods
Ability to compose professional documentation (Write protocols, work instructions, etc.)
Ability to manage time and projects effectively while setting and meeting aggressive schedules
Ability to analyze and solve problems utilizing root cause analysis tools
Quality minded person with a focus on making data driven decisions
Ability to understand business, legal and regulatory requirements
Ability to learn regulatory requirements, FDA 21 CFR 820/GMP Medical Device Regulations
Key Performance Objectives
Short Term: (0 to 3 months)
Learn KEIND Quality system requirements
Build relationships with team members
Begin documenting and developing process flows for launch of critical medical device product.
Design equipment or tooling to support a manufacturing process
Write technical documentation
Assist in validation efforts for commissioning of production systems
Maintain customer specific system documentation in support of FDA regulatory requirements
Learn and adopt Kimball Electronics philosophies and culture
Work with project managers in the execution of project plans
Participate in risk assessment activities (PFMEA, DFMEA)
Participate in Lean manufacturing training and projects