Associate Director, Device Engineering

Minimum of 10+ years of experience in medical device or combination product development, with at least 3 years in a team leadership role

Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch, including authoring clinical and commercial regulatory submissions

Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer

Kailera Therapeutics, Inc.

Kailera Therapeutics, Inc.

Familiarity with combination product regulations (21 CFR Part 4)

We are seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens.

This role will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust product development aligned with meeting patient needs, global standards, and regulatory expectations.

Lead combination product development projects (prefilled syringes, autoinjectors, and/or multidose pens) from concept through commercialization

Develop device and combination product requirements, including user and stakeholder needs and technical requirements, and ensure appropriate engineering translation and subsequent verification and validation of requirements

Oversee and ensure compliance with design controls per FDA and ISO 13485 requirements

Drive design verification and validation activities, including test method development, protocol execution, and documentation