ZipRecruiter
Senior Mechanical/Device Engineer
ZipRecruiter, San Francisco, California, United States, 94199
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr