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Dragonfleye Therapeutics Corp.

Development Engineer

Toronto, ON, Canada

Full-time

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Job details

Job type: Full-time
Apply by: May 5, 2027
Experience: Experience. 3 to 7 years in medical device development.
Posting language: English
Posted: Nov 6, 2026

Original job description

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.

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More about this job

Responsibilities

Carry assigned medical device programs through the design-control lifecycle to verification, including design inputs and outputs, DHF progression, traceability, and verification planning and execution. Coordinate technical work with internal engineers, contract manufacturers, suppliers, and Quality, and compile test results and close outstanding items.

Requirements

Requires a bachelor's or master's degree in mechanical, biomedical, or a related engineering discipline and 3–7 years of medical device development experience. Candidates must have experience carrying programs through design controls and V&V under FDA QMSR (21 CFR 820) and ISO 13485, as well as serving as a technical interface to external design and manufacturing partners.

Skills

Medical Device Development
Design Controls
Design History File (DHF)
Verification and Validation (V&V)
Design Traceability
FDA QMSR (21 CFR 820)
ISO 13485
Vendor Technical Support
Design Transfer
Verification Testing
Test Protocol Development
Risk Management
Design of Experiments (DOE)
Applied Statistics
Cross-Functional Collaboration

Benefits

Stock Options

Visa sponsorship

Not detected in the job text

Keywords

Ophthalmic Medical Devices
Ocular Devices
Trans-Scleral Injector
Suprachoroidal Delivery
Subretinal Delivery
Resorbable Implants
Medical Device Development
Design Controls
Design Inputs
Design Outputs
Design History File (DHF)
Verification and Validation (V&V)
Design Traceability
FDA QMSR
21 CFR 820
ISO 13485
Contract Manufacturers
Supplier Collaboration
Design Transfer
Verification Testing
Test Protocols
Test Methods
Risk File
Design of Experiments (DOE)
Applied Statistics
IDE Development
PMA Development

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