Associate Director​/Director, Device Development

Associate Director / Director, Device Development

Skylark Bio|Cambridge, MA|Full-time|On-site

Most device engineers spend their careers optimizing products that already exist. This role is different. At Skylark Bio, you’ll refine the design and develop the delivery device for gene therapy trials for children who cannot hear. The device doesn’t exist yet ’ll build it.

We’re a Series A gene therapy company with a lead program already in the clinic. We move fast, make real decisions, and don’t have layers between you and the work that matters.

You’ll lead everything from prototype to manufacturing transfer including design controls, verification and validation, regulatory strategy, and partner management. You’ll be the device expert in the room across clinical, chemistry, manufacturing, and controls (CMC), and regulatory conversations. You’ll write the device sections of regulatory submissions. You’ll pick the right external partners and hold them accountable.

This isn’t a support role. You’ll set the strategy and execute it.

• More than 7 years of experience in medical device or drug-device combination product development.
• Track record taking a sterile device from early development through design transfer.
• Deep working knowledge of International Organization for Standardization (ISO) 13485, ISO 14971, and Food and Drug Administration (FDA) quality system regulations.
• Experience managing external partners – manufacturers, engineering firms, testing labs.
• Ability to author device-related regulatory submissions, including Investigational New Drug (IND) sections.
• Biotech experience is a plus, not a requirement. What matters more: you’re done optimizing at another company and ready to build at a small one.

We’re working on diseases where there are no good options. Pediatric hearing loss. Central nervous system (CNS) disorders. Monogenic diseases where a single correct gene could change a child’s life.

The science is real. The clinical program is active. The team is small enough that your work will be visible and your decisions will matter.