Principal Medical Device Engineer (Design Control/CFR)

Very occasional need to have candidates work later into the day due to occasional set up that may be needed. Approximately 1-2x per month. International travel may be required for this position. Job Summary Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The Principle Engineer will work closely with team members to develop detailed engineering specifications, device design & development, and support verification, validation, and regulatory submissions of these devices. The role is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Responsibilities Work cross-functionally with individuals and project teams in Marketing, Operations, and Development. Create and assess product requirements to determine technical coverage and proper integration of different subsystems. Create and execute project plans and schedules. Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plans, verification and validation plans, and other related product development documents for assigned projects. Provide deep technical assistance for junior engineers. Qualifications BS in Engineering and 10+ years of experience in a medical device industry. Experience with engineering processes and procedures, and led projects from development through the 510(k) and PMA approval process. Strong background in engineering and commercialization of electro-mechanical medical devices. Experience with material & test specifications generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) and U.S. (FDA/PMA/510(k) submissions). Experience in drug/device combination product design and development. Familiar with Quality System Regulation (21CFR820), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), Medical Electrical Equipment (EN 60601). Small-scale device assembly experience. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Strong problem-solving, risk assessment, and risk-management skills. Must be capable of working on multiple projects in a deadline-driven environment. Must-Have Skills DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. Packaging process experience is a plus. Day-to-Day Responsibilities Position involves support of Senior Staff on initiation, design, and delivery of projects, particularly for Packaging Equipment C&Q, Characterization and Validation. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third-party firms. Important Note Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered! #J-18808-Ljbffr Infotree Global Solutions