Contract Assignment 12+ Months M-F 40 hours weekly.
The position will start remote, and phase in to 1 to 2+ days per week at the client.
Bachelor’s degree in engineering discipline such as bio-medical, systems, software, electrical, or mechanical engineering. Master’s degree preferred The candidate will interface with Hardware and Firmware of a stand only box, patient monitoring.
The selected candidate will have 10 plus years of working in a regulated environment, preferable Medical or DOD... Must have Excellent communication skills with a high degree of detail written oriented work.
The engineer will be a hands on individual contributor and will also be responsible for running requirement review meetings. The candidate must be able to communicate and technical understand the interface between hardware and software, then write and review those requirements. Each requirement will consist of over 50 attributes.
The selected candidate will serve as key user for the Requirement Management
Proficiency in using requirements management tools (DOORs). Demonstrated understanding of system engineering principles and best practices (INCOSE membership a plus) Demonstrated technical leadership ability Highly organized and communicative (strong verbal, and written abilities) Working knowledge of medical device product development and/or experience developing products within a highly regulated environment
Responsible for translation of product requirements into technical system requirements (TSRs) and/or technical sub-system requirements (TSSRs) for new products and feature enhancements to existing product portfolio with the collaboration of contributing disciplines (e.g. Electronics, Mechanics, Software Engineering, Clinical Engineering, Product Qualification, Risk Management, and Production
You will collaborate with Platform Designers, System Risk Managers, and System Architects for the purpose of ensuring that requirements meet the needs of the patient monitoring portfolio.
Job Status: Contract/Temporary