Senior/Principal Device Engineer in Fremont

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Job Description

About CoFlo

CoFlo Medical’s core annular flow devices reduce drug delivery injection forces by >200x, unlocking high-concentration, high-viscosity delivery beyond 1,000cP. CoFlo is collaborating with biopharmas to develop high-dose combination products that enable low-cost, less-frequent, and at-home treatment. Founded out of MIT and venture-backed, our team is reimaging healthcare with the mission of increasing patient access to life-saving therapies.

What You’ll Do

You’ll join our team as a Senior or Principal Device Engineer on the journey from early stage to FDA-ready device. You will lead and execute a wide range of device engineering responsibilities to enable CoFlo’s progression through proof of concept, manufacturing scaleup, first-in-human, submission, and marketing. You will contribute to delivery devices across modalities, from large- and small-volume subcutaneous delivery to intravitreal injections and more. Your responsibilities will include:

• Drive device design from user needs through design freeze
• Organize and execute verification testing, human factors, and risk mitigation
• Manage vendor selection, tooling, sterilization, and packaging development
• Author data packages and documentation for regulatory submissions

Requirements

• BS or higher in related field
• >5 years of experience in medical devices
• Desire to work in a fast-paced, high-agency environment
• Proven track record in most or all of the following: Design Controls and Risk Management, Design Transfer, Vendor Management (CRO, CMO, testing, etc.), User Needs and Human Factors Engineering, Verification and Validation
• Experience with needle-based injection device systems

• (Bonus) Literacy in specific needle-based injection system standards (ISO 11608, 11040, 10993, 11135)
• (Bonus) Startup or small-team experience

What We Offer

An opportunity to make a visible impact on a meaningful medical device and to grow with a fast-paced company. We also offer competitive salaries, early-employee equity, 401(k), health, dental, and vision insurance. Title will be commensurate with experience.

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