Hiring: NPD Engineer
Location: North Chicago, IL 60064
We are looking for an Engineer II to support the development, testing, characterisation, and scale-up of medical devices, drug-device delivery systems, and combination products.
Key Responsibilities:
Support medical device and combination product development
Perform DOE, product, functional, and reliability testing
Analyse data and prepare reports/presentations
Support design verification, validation, and risk assessment
Support process development, optimisation, and scale-up
Troubleshoot manufacturing and product issues
Prepare SOPs, validation documents, and technical reports
Collaborate with Quality, Regulatory, Manufacturing, and external teams
Requirements:
BS in Engineering, Biomedical, Biotechnology, Pharmaceutical, or related field
Experience in product/engineering development
Medical device, drug delivery, or combination product experience
Hands-on lab testing and DOE/data analysis experience
Knowledge of design controls, V&V, FDA, ISO, and cGMP
Manufacturing/product development experience preferred
Drug delivery devices, pumps, syringes, auto-injectors, or battery-powered devices are a plus
Strong communication, technical writing, and teamwork skills