Job Description

Job Description 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 Principal Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Principal Engineer 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 previous experience in a medical device industry – 10 years current experience with engineering processes and procedures. Led projects from development through the 510k and PMA approval process. Strong background in engineering and commercialization of electro‑mechanical medical devices. Experience with material & test specs 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) & US (FDA/PMA/510k) submissions. Experience in drug/device combination product design and development. Familiar with the following standards: 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. Important Note Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need to apply and will be considered!!! #J-18808-Ljbffr ACL Digital

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