Job title: Engineer I Location: New Haven, CT Duration: 12 Months to begin with Position Summary This position will serve the role of Engineering Contingent for device development , including continuous product improvement within the Development function. The candidate will support technical design and development activities for device and combination products and assist the technology transfer. Principal Responsibilities Manage medical device test method and specification development, including test method development, validation, transfer, and life cycle management. Support laboratory operations such as sample inventory, equipment qualification, and maintenance. Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and traditional engineering techniques. Test mechanical or electromechanical systems on bench top models or production representative units during design development and verification. Liaise with third parties such as specialist manufacturers and toolmakers. Communicate effectively, both verbally and in writing, internally across departments and with external suppliers. Comply with the Company’s quality assurance requirements as well as applicable regulatory requirements. Qualifications Experience in design control activities. Knowledge of primary containers and drug delivery. Understanding of mold and fixture design and build, as well as application of validation processes (IQ/OQ/PQ). Experience interfacing with medical device vendors and tooling companies. Knowledge of regulatory and compliance requirements of device design controls and combination products (i.e., FDA QSR 21 CFR Part 4 and 820 / ISO 13485 quality system requirements).
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