Medical Device Development Engineer - Regulatory
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About The Position
Lynntech is seeking an experienced engineer with a background in new electromechanical medical device development to help build our capability to transition technologies and regulated devices into the marketplace. The Engineer will be involved in the following activities as part of a team of technical and regulatory experts: Defining indications for use and intended use, capturing user needs and developing design inputs, leading risk analyses and risk evaluations in accordance with ISO 14971, developing Safety Assurance Cases in accordance with FDA guidance, facilitating device design documentation and development processes in accordance with ISO 13485, reviewing draft test protocols, supporting regulatory strategy development for new devices, identifying potential predicate devices and reference devices, preparing design documentation in support of presubmission meetings with the FDA and other stakeholder meetings, and supporting creation and maintenance of Design History File documentation. This position requires both technical expertise and familiarity with regulated medical device documentation and activities and plays a key role in facilitating effective communication of information between technical teams and regulatory affairs teams. The ideal candidate will be able to help technical teams assess their designs from a regulatory and risk management perspective as well as help regulatory personnel understand and frame the technical aspects of the design in a regulatory context.
