Kimball Medical Solutions is a Medical Device Contract Manufacturer in Indianapolis, IN. This is a 100% onsite position. We provide 3 weeks of PTO starting your 1st year in addition to 10 paid holidays. Annual profit sharing bonus based on company performance. Major health, dental, vision, and complementary insurances 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 processes have alignment with the validation strategies and quality procedures and will report to the Automation Team Leader. You will assist in the development of vision and programming standards and source code reviews for automated equipment. Provide guidance to suppliers on new equipment builds, analyze production equipment performance and develop plans to increase yield from underperforming inspections. You should be able to manage projects that may compete for your time while keeping accurate records of work. 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 and we would like a mastery of at least one of those systems. 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 Kimball Electronics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, genetic information, disability or protected veteran status. Kimball Electronics is a leading contract manufacturer of durable goods electronics serving a variety of industries on a global scale. Kimball Electronics continues to make the customer the focus of everything we do and will continue to provide the highest industry quality through continuous improvement. What makes us different? We share the organization's vision and goals, and acknowledge that achieving them is only possible with the dedication and skills of our employees. We demonstrate confidence in employees' ability to make positive contributions beyond their day-to-day job duties. We create very specific opportunities for worker involvement, but also make it clear that input is welcome at any time. We provide training to help employees develop, present and carry out their ideas. *We coach managers to facilitate rather than instruct, and hold them accountable for encouraging and supporting improvement and innovation within their department. We empower workers to implement small-scale changes on their own, and keep them apprised of the status of those requiring management approval. We recognize employees not only for their achievements, but also their efforts.