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Learn more about our medical contract manufacturing here: Kimball Medical Solutions
Benefits:
Kimball Medical Solutions provides 3 weeks of PTO starting your 1st year in addition to 10 paid holidays. Potential for annual profit sharing bonus based on company performance. Major health, dental, vision, and complementary insurances offered starting day 1. We offer a 50% match on your first 6% of 401k contribution with opportunity for an employer contribution annually.
Quick Summary
As Automation Engineer, you will ensure that all automated manufacturing processes have alignment with the validation strategies and quality procedures. You will assist in the development of vision and programming standards and source code reviews for automated equipment. You will provide guidance to suppliers on new equipment builds, analyze production equipment performance and develop plans to increase yield from underperforming inspections.
The ability to manage projects that may compete for your time while keeping accurate records of work is crucial for this role. In our business, it is critical you can demonstrate a solid understanding of the importance of quality and documentation. You will be working with Allen Bradley PLC’s, Cognex Vision systems, and Fanuc Robots. Mastery of at least one of those systems is preferred.
Basic Background Requirements:
- 2+ years of experience in Automated Manufacturing.
- Validation experience, process and equipment qualification (IQ,OQ,PQ), Test Methods are a plus.
- Compose professional documentation (Write protocols, work instructions, engineering studies, etc.).
- Manage time and projects effectively while setting and meeting ambitious schedules.
- Knowledgeable on regulatory requirements, FDA 21 CFR 820/GMP Medical Device Regulations.
- Working knowledge of Minitab.
- Knowledge of statistical techniques and sampling for process validation and process monitoring is desired.
Key Performance Objectives:
Short Term: (0 to 3 months)
- Learn KEIND Quality system requirements
- Train on processes required to validate processes in the KEIND quality system
- Build relationships with others
- Begin training on the manufacturing line and the technology in use on the Automated Equipment
- Maintain customer specific system documentation in support of FDA regulatory requirements
Midterm: (3 to 6 months)
- Begin to audit current validations and identify solutions
- Develop an understanding of completing engineering changes on the Automated Equipment and maintaining the validated state of the equipment
- Learn and adopt Kimball Electronics philosophies and culture
Long term: (6 to 12 months)
- Identify process improvement areas and develop a plan to implement those improvements
- Write and complete test method validation and equipment qualifications
- Demonstrate understanding of and attend training to FDA 21 CFR 820/GMP Medical Device Regulations
Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Kimball Electronics we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
We’re proud to be an equal opportunity employer and consider qualified applicants without regard to race, color, religion, sex, national origin, ancestry, age, genetic information, sexual orientation, gender identity, marital or family status, veteran status, medical condition or disability or any other characteristic protected by applicable federal, state, or local law.
We will consider for employment qualified candidates with arrest and conviction records, consistent with applicable law (including, for example, the San Francisco Fair Chance Ordinance for roles based in San Francisco).
