Job Description

We are seeking a Development Engineer who will support the design, development, and lifecycle management of a nasal inhalation device used in a drug-device combination product. This role will also play a key part in supporting manufacturing activities and implementing device-related changes in collaboration with contract manufacturing partners. The position requires deep technical expertise in inhalation systems, along with the ability to bridge development and commercial manufacturing environments.

Responsibilities

• Lead and support the design and development of device components and systems for nasal inhalation products
• Own and contribute to design control deliverables, including design inputs/outputs, verification, and validation activities
• Conduct and oversee device performance testing (e.g., spray characterization, dose uniformity, functional testing)
• Support risk management activities, including hazard analysis and FMEA
• Collaborate cross-functionally with Quality, Regulatory, Clinical, and Manufacturing teams
• Partner with contract manufacturers to support device production, troubleshooting, and continuous improvement
• Lead and support the implementation of manufacturing and design changes, including change control and impact assessments
• Ensure design changes are properly evaluated, verified/validated, and documented in accordance with regulatory requirements
• Support design transfer and ensure alignment between development and commercial manufacturing processes
• Participate in investigations related to device performance, nonconformances, and CAPAs

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, or related Engineering field
• 10+ years of experience in medical device or combination product development
• Hands-on, in-depth experience with nasal inhalation systems, including device design, functionality, and performance testing (e.g., spray characterization, dose uniformity), with application to design controls and product development activities
• Experience supporting manufacturing activities and implementing device or process changes, preferably in collaboration 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

Location

• Remote

Employee Type

• W2 or 1099

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp-to-permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled