Associate Director, Device Engineering: Autoinjectors & PFS

Kailera Therapeutics, Inc.; United States; Híbrido; USD 159.000 - 195.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Disability insurance

Life insurance

Equity grants

Annual bonus opportunities

Descripción de la vacante

Kailera Therapeutics, Inc. is seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with emphasis on autoinjectors, pre-filled syringes, and multidose pens.

This role drives cross‑functional collaboration to ensure robust product development aligned with patient needs and regulatory expectations. Required location: Waltham, MA onsite 3–4 days per week or remote with hub visits; responsibilities include leading

Formación

• Minimum 10+ years in medical device or combination product development.
• At least 3 years in a team leadership role.
• Experience with autoinjector, pre-filled syringe, or multidose pen programs.
• Strong knowledge of design controls, verification, risk management, and usability.

Responsabilidades

• Lead development of drug-device combinations from concept through commercialization.
• Create and manage project plans with defined risks and milestones.
• Develop device requirements and verify/validate design outputs.
• Oversee design controls per FDA/ISO 13485 and risk management per ISO 14971.
• Coordinate usability engineering and human factors per FDA/IEC guidance.
• Drive design transfer to manufacturing and cross-functional integration.
• Contribute to regulatory submissions for devices and combo products.

Educación

Bachelor’s degree in Mechanical Engineering

Advanced degree preferred

Herramientas

PMP certification

Descripción del empleo

Kailera Therapeutics, Inc. is seeking an experienced Associate Director, Device Engineering, to lead the development and launch of drug-device combination products, with emphasis on autoinjectors, pre-filled syringes, and multidose pens.

This role drives cross‑functional collaboration to ensure robust product development aligned with patient needs and regulatory expectations. Required location: Waltham, MA onsite 3–4 days per week or remote with hub visits; responsibilities include leading