Research and Development/Production Process Engineer

ob Description Take on full responsibility for the coordination and management of all equipment and process IQ’s, OQ’s and PQ’s Monitor and improve BIOVIC’s manufacturing processes with respect to yield and throughput Coordinate and manage all production process validations Coordinate and manage process validations of new products and line extensions Assist with increasing production capacity by streamlining and wherever possible automating manufacturing processes Keep all process FMEAs up to date Job Requirements Candidate must have at a minimum a bachelor’s degree in an engineering or science discipline At least 4-5 years’ work experience in this field required; medical device background preferred Experience with ISO 13485 quality system is required, product/process FMEA will be a plus Must be able to understand and familiarize oneself with company’s multi-step manufacturing process (training will be provided). Must be familiar with writing and performing equipment and process IQ’s, OQ’s and PQ’s Must be familiar with writing and running process validations Must be comfortable with basic statistics and statistical software, familiarity with Design of Experiments is preferred Must demonstrate proficiency with following SOP’s, and must have good attention to detail. All protocols and reports must be in English, as such excellent spoken & written English skills are required. A diverse skillset is preferred as we work as a team, and may need to assist other departments