Device Development Engineer, Digital Devices

DEVICE DEVELOPMENT ENGINEER, DIGITAL DEVICES NEW BRUNSWICK, NJ Manager is seeking a candidate to work remote but must be local to the area. Project Description: The Device Development Engineer, Digital Devices position will be responsible for authoring technical documents for the development of combination products, with emphasis on the medical device constituent part (electro-mechanical, and SaMD), according to relevant Design Control regulations and standards. The position will also be responsible for providing project specific support, including technical analysis and review of supplier documentation as required. The position will report to the Associate Director, Device Development.

• Author and maintain project specific documents according to design controls to support the development of devices and combination products.
• These include, but are not limited to Design & Development Plans, Design Input/Design Trace Matrix, Software Development Plans, Risk Management Plans, Specifications, Test Methods, System Diagrams, Interaction Diagrams, Data Flows, Logical & Physical Architecture Diagrams, Design Verification Summary Reports, and Design Transfer documentation.
• Review of device design suppliers' documentation and expert judgement on how to most efficiently support the DHFs.
• Collaborate with suppliers and the Client's functions to ensure appropriate documents are transferred or linked to build compliant DHFs.
• Responsible for assessments of proposed changes related to project documentation.
• Author relevant technical sections of regulatory briefing books, submissions (IND, BLA, MAA, 510K), and other technical documentation as required.
• Participate on design review teams and in technical assessments.

• BS in Electrical, Biomedical Engineering, Computer Science, or related discipline.
• Excellent communication (written and verbal) skills.
• At least five years of hands-on experience in the development and commercialization of electro-mechanical and/or digitally connected drug delivery injection devices.
• Experience with combination product development is a plus.
• Working knowledge of worldwide pharmaceutical/ medical device regulations, including 21 CFR 820, ISO 13485 and how they apply to software and hardware development.
• Direct experience with IEC 62304, IEC 60601, and ISO 14971.