Job Summary

Support development of novel electrical aerosol drug delivery device and other drug delivery systems, help establish and manage device design history file (DHF) and technical file; ensure contents are adequate to support regulatory submissions. Support interdepartmental activities with respect to device design development, prototyping, assembling, design verification/validation, stability testing, design cycle and verification testing, specification development, investigations, testing to regulatory standards, etc.

Responsibilities

• Support design development and documentation of test analog and digital electronics for drug delivery devices
• Conduct in-house prototyping and testing of new device designs, test fixtures, cabling, generate test protocols and analyze/document test results in laboratory notebooks, write test reports and maintain engineering records to GMP standards
• Coordinate and work with certified test laboratories to perform testing of device to electrical safety and EMC standards such as IEC 60601
• Prepare technical engineering documentation including specifications, hardware design description, electrical schematics, risk analyses, engineering drawings, specification control drawings, block diagrams, electrical design documents, etc.
• Manage engineering lab (organize storage, maintain supplies, ensure users keep lab orderly and adhere to safety practices)
• Maintain engineering equipment. Ensure measurement equipment in engineering lab is in calibration and update status in BMRAM (or replacement system when implemented). Support QC in calibration of some equipment (Human Breath Profile Simulator (HBPS))
• Interact with suppliers/vendors to help design/select components for product devices
• Contribute to intellectual property evaluations
• Participate in multiple project teams

Skills required

• Experience with hands-on electronics (soldering, testing, etc.) in the medical device or other regulated industry
• Analog and digital circuit design and analysis
• Experience with test fixture design using LabVIEW and other tools
• Excellent oral and written communication skills as well as strong interpersonal skills
• Well versed in Food and Drug Administration (FDA) regulations for medical devices and products, especially as it relates to building and maintaining a DHF and technical file
• Experience working in compliance with GMP regulations

Education and experience

• BSEE or higher or an equivalent foreign degree in Electrical Engineering or similar
• 6-10 years of experience in hardware, design, electrical, or electronics engineering related to the development of medical devices; aerosol drug delivery device experience is a plus

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel

Compensation:

The annual base salary for this role starts at $150,000. Individual title and pay may vary based on additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health benefits, an LTI plan, and an annual target bonus for full-time positions.