Snr Principal Engineer

Location United States of America
Job type: Permanent
Contact name: Sam Murphy

Contact email: sam.murphy@rbwconsulting.com
Contact phone: 6175951613
Job ref: 6780954345679
Published: 7 months ago
Expiry date: 30 Aug 2024 23:59

​The device engineer will be responsible for commercial manufacturing processes including semi-automated to automated and large-scale manufacturing and assembly operations. This position will be focused on orally inhaled and nasal drug products (OINDPs). The device engineer will interface with early device design teams and be responsible for independently providing direction, initiation, planning, coordination, implementation, execution, control, and completion of specific device project(s) ensuring consistency with organizational strategy, commitments, and goals. This is a hands-on position that requires daily tactical responsibilities leading up to strategic decisions.

Qualification Requirements:

  • M.S. in Mechanical Engineering, Electrical Engineering, Material Sciences, or a related discipline with 6 to 9 years, or B.S. with 12 to 16 years of device development experience in the pharmaceutical or related field.

  • Experience with device development and manufacturing in the context of pharmaceutical R&D and product development is essential.

  • Expert knowledge and experience with commercial scale device manufacturing and assembly processes including manual, semi-automated, and/or commercial scale automated processes.

  • Expert knowledge of manufacturing processes including injection molding and metal machining processes.

  • Expert knowledge of mold tool design, optimization, qualification, and life-cycle management.

  • Expert knowledge of mechanical design with a preference for SolidWorks.

  • Expert knowledge of tools to conduct statistical and tolerance analysis.

  • Knowledge of regulations and standards including US 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, EU MDR, etc.

  • Experience in developing orally inhaled and nasal drug products (OINDPs) is a plus.

  • Experience with Notified Bodies and CE marking is a plus.

  • Strong English language skills, including writing ability and oral communication.

  • Good judgment as well as cultural, social, and environmental awareness.