R&D Engineer - Medical device

Job Title: R&D Engineer - Medical device Location: New Albany, OH (Onsite) Duration: 12+ Months We are seeking an experienced Process Development Engineer with a strong background in medical device or combination product development to support the design, development, validation, and commercialization of drug delivery devices. The ideal candidate will have experience working with electro‑mechanical medical devices and cross‑functional product development teams. Key Responsibilities: Lead cross‑functional engineering teams in the design and development of mechanical and electro‑mechanical drug delivery devices. Drive projects from concept through commercialization, including design verification, validation, and regulatory support. Develop engineering specifications, project plans, design documentation, validation plans, test protocols, and reports. Collaborate with R&D, Manufacturing, Quality, Marketing, and Operations teams throughout the product development lifecycle. Support process development, packaging and assembly activities, and manufacturing readiness. Perform risk assessments using FMEA and support Design Controls in accordance with FDA regulations. Execute process validation activities including IQ/OQ/PQ. Support continuous improvement initiatives and provide technical guidance to junior engineers. Required Qualifications: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline. Experience in medical device or combination product development. Strong experience with electro‑mechanical medical devices. Hands‑on experience with Design Controls and product development lifecycle. Experience with drug/device combination products. Knowledge of FMEA, DOE, SPC, and statistical process improvement. Experience performing IQ/OQ/PQ Process Validation. Experience writing validation protocols, engineering reports, and technical documentation. Experience with prototyping, design verification, and validation. Strong communication and cross‑functional collaboration skills. #J-18808-Ljbffr Intellectt Inc