Development Engineer, Ocular Devices
Dragonfleye is looking to add a Development Engineer to their Ocular Device team. This is a highly hands on role and will work cross-functionally with Quality & Design, Program Management as well as contract manufacturers.
ABOUT DRAGONFLEYE
Dragonfleye is a near-clinical-stage ophthalmic medical device and biotechnology company building a precise, minimally invasive delivery platform for the eye: a trans-scleral injector platform that delivers therapeutic payloads, including resorbable implants, to the suprachoroidal and subretinal spaces. This role is the engineer who carries our device programs through the design-control lifecycle to verification, coordinating the people, vendors, and evidence that get a design to done.
WHY THIS ROLE MATTERS
This is less a bench-design seat and more a project-carrying, design-controls-through-V&V role. You take a program's design through the full design-control process to verification. You work with the vendors who do the detailed design and build, the internal design engineers, and Quality, and you make sure the evidence and the record come together. It is a highly collaborative role: much of the work is shared, and you are the technical thread that keeps a project moving through to completion.
WHAT YOU'LL OWN
Design controls through V&V
- Carry assigned programs through the design-control lifecycle end to end (design inputs and outputs, DHF progression, verification planning and execution, and traceability), driving each to completion through V&V.
Vendor technical support
- Serve as the technical interface to our contract manufacturers and suppliers: reviewing their design outputs, resolving technical questions, and supporting design transfer. The Director of Program Management owns the vendor relationship, schedule, and commercial terms; you own the technical content.
Collaboration with Quality
- Work hand in glove with Design Assurance: you carry the design-control deliverables and drive verification; Quality independently assures the protocols, risk file, and sign-off, so the work is always checked by someone who didn't produce it.
Collaboration with design engineers
- Partner with the internal design engineers and vendors who produce the detailed design; integrate their work into the controlled design record and drive it through verification.
Verification execution
- Plan, coordinate, and execute design-verification testing; compile and interpret the results; and drive open items to closure.
MUST-HAVE QUALIFICATIONS
- Education. BS or MS in mechanical, biomedical, or a related engineering discipline.
- Experience. 3 to 7 years in medical device development.
- Design controls & V&V. Has carried programs through the design-control lifecycle to verification (design inputs and outputs, DHF, V&V, and traceability) under FDA QMSR (21 CFR 820) and ISO 13485.
- Vendor collaboration. Experience serving as the technical interface to external design and manufacturing partners, including design transfer.
- Collaboration. Comfortable with shared ownership across Quality, Program Management, internal engineers, and vendors; keeps projects moving by influence.
- Disposition. Organized, thorough, and effective in a lean, fast-moving startup; owns the thread through to done.
PREFERRED QUALIFICATIONS
- Ophthalmic devices; suprachoroidal, subretinal, or other back-of-eye delivery; injector or implant experience.
- V&V protocol and test-method familiarity; DOE and applied statistics.
- Experience through IDE or PMA development programs.
WHAT WE OFFER
- A pivotal role connecting design, vendors, and quality across the portfolio, breadth across programs, and participation in the company's stock option plan.
- Work that matters. Help patients with ocular disease by advancing a novel platform designed to make ophthalmic treatments more precise and less invasive, with the potential to improve treatment, recovery, and quality of life.
- Visibility. Work closely with leadership, where your data and contributions are seen and valued.
