Medical Device Engineer/Principal

Job Title Medical Device Engineer/Principal Location New Albany, OH Duration 12 Months Description Onsite AOH – Monday to Friday – Standard 8‑hour day. Very occasional need to work later into the day for setup; approximately 1–2 times per month. International travel may be required. Top 3 Must Have Skill Set DOE/SPC process optimization & validation (IQ, OQ, PQ), FME Nice to Have Packaging process experience Responsibilities Lead teams in the development of drug delivery devices, including needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro‑infuser delivery pump systems. Ensure successful device development of these mechanical and electro‑mechanical medical devices. Work closely with team members to develop detailed engineering specifications, device design and development, support verification, validation, and regulatory submissions. Work within a cross‑functional organization using technologies and methodologies that support short‑cycle robust device development. 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 plan, verification and validation plans and other related product development documents for assigned projects. Provide deep technical assistance for junior engineers. Skills BS in Engineering and previous experience in a medical device industry. 10+ years of experience with engineering processes and procedures. 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, 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 EMEA (CE Mark) and US (FDA/PMA/510(k)) submissions. Experience in drug/device combination product design and development. Familiar with Quality System Regulation (21 CFR 820), 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. Basic Qualifications Doctorate degree and 3 years of experience. Master’s degree and 5 years of experience. Bachelor’s degree and 7 years of experience. Associate’s degree and 12 years of experience. High school diploma / GED and 14 years of experience. Additional 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 ACL Digital