REMOTE - Device Engineer

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Posted 5 days ago United States Salary undisclosed
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Job Description

Insight Global is looking for Device engineer for one of our fast growing clients building new Gigafactory. You will be a part of a team of 9 engineers working to produce new processed from the ground up with new facility across multiple locations in the USA. Lead the ongoing design / sustaining engineering activities related to clients device technology, including design reviews, technical reviews and the implementation of statistically justified design changesDevelop and direct engineering team in the development of verification test protocols per applicable medical device standards.Oversee design transfer processesParticipate in technical investigation of customer complaints Minimum RequirementsWorking knowledge of the medical device regulatory environment and applicable regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, ISO 14971.Experience leading the medical device design control and development process, including risk management, design transfer and sustaining manufacturing / engineering activitiesProviding statistically sound guidance and justifications for design changes, qualification and verification/validation activitiesDriven, energetic, self-assured professional with high personal integrity. Ability to develop effective, positive interpersonal relationships.Solid experience in developing and commercializing regulated devices/combination products under Design Control (21 CFR 820 or ISO 13485) and ISO 14791 requirementsSolid understanding of global industry standards (ex. ISO, AAMI, ANSI, etc.)Proficient in MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)