Engineer Senior, Drug Delivery Devices (JP11638)

3 Key Consulting is recruiting an Engineer Senior, Drug Delivery Devices for a consulting engagement with a leading global biotechnology company. The role involves leading technical teams to develop drug delivery devices, including needle protection systems, fluid transfer devices, and micro-infuser delivery pump systems.

Requirements

• BS in Engineering and previous experience in a medical device industry, supply chain and QA in a medical 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
• Experience in drug/device combination product design and development
• Familiar with the following standards: o Quality System Regulation 21CFR820 o Risk Management ISO 14971 o EU Medical Device requirements Council Directive 93/42/EEC o Medical Electrical Equipment EN 60601
• Small scale device assembly experience