Senior Mechanical/Device Engineer

Job Description

CoFlo is a startup spinning out device technology developed at MIT to enable low-cost, patient-first administration of lifesaving drugs. Our device platform dramatically (>100x) improves the delivery of high-viscosity biologics and other challenging formulations—expanding access, improving outcomes, and transforming the patient experience.

We’re seeking a Senior Mechanical Engineer to be a cornerstone of our technical team and drive the design and development of our drug-delivery device platform. As an early hire, you will shape and contribute to the full product development lifecycle — bringing concepts and prototypes to clinical readiness.

This is a hands-on role for an engineer who thrives in fast-paced environments, takes initiative, and is motivated by the opportunity to help shape a high-impact medical device from the ground up.

Key Responsibilities

• Lead mechanical design, taking prototypes and concepts to clinical readiness.
• Drive rapid prototyping, testing, and iteration cycles.
• Own design for manufacturability (DFM) and assembly (DFA).
• Oversee vendor relationships and guide scale-up for pilot, low-volume, and future high-volume manufacturing.
• Manage regulatory documentation and risk management activities, including FMEAs etc.
• Collaborate cross-functionally with founders, advisors, and external partners to align device design with clinical, regulatory, and business goals.

Qualifications

• 5+ years of experience in mechanical design, preferably within medical devices or other regulated products.
• Proven track record of taking products from concept through V&V, regulatory readiness, and into manufacturing.
• B.S. or higher in Mechanical Engineering, Biomedical Engineering, or related field.
• Proficiency in rapid prototyping and fabrication (3D printing, machining, molding, etc.).
• Experience with design controls, risk management, and regulatory standards (ISO 13485, ISO 14971, 21 CFR Part 11).
• Bonus: Experience with drug-delivery systems (injectors, pumps, infusion sets, etc.), human factors engineering, or combination products.
• Bonus: Familiarity/Expertise in fluid dynamics.