Development Engineer
Remote · United States
Job Summary
Development Engineer for nasal inhalation device development and manufacturing support. Responsibilities include leading design and development of device components for nasal inhalation products, owning design control deliverables (inputs/outputs, verification, validation), conducting device performance testing (spray characterization, dose uniformity, functional testing), supporting risk management (hazard analysis, FMEA), cross-functional collaboration with Quality, Regulatory, Clinical, and Manufacturing, partnering with contract manufacturers for production, implementing manufacturing and design changes with change control, ensuring proper evaluation/verification/validation of changes per regulatory requirements, supporting design transfer and alignment between development and commercial manufacturing, and participating in investigations related to device performance, nonconformances, and CAPAs.
Required Qualifications
- Bachelor’s degree in Mechanical, Biomedical, or related Engineering field
- 10+ years of experience in medical device or combination product development
- Hands-on experience with nasal inhalation systems, device design, functionality, and performance testing (e.g., spray characterization, dose uniformity)
- Experience supporting manufacturing activities and implementing device or process changes, preferably with contract manufacturers
- Strong knowledge of design controls, risk management (ISO 14971), and combination product regulations
- Experience with design transfer and commercial manufacturing support
- Strong problem-solving skills and ability to work across internal teams and external partners
- Ability to bridge development and commercial manufacturing environments
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