Senior Device Engineering Lead – Autoinjectors

Kailera Therapeutics; United States; Hybrid; USD 159,000 - 195,000; Full time

Benefits offered by this job

Health coverage

Flexible time off

Paid holidays

Wellness stipend

401(k) match

Tuition reimbursement

Commuter benefits

Equity grants

Annual bonus

Job summary

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

You will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust development aligned with patient needs and regulatory expectations.

Qualifications

• 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 development and launch.
• Strong knowledge of FDA/ISO 13485 design controls, risk management, and design transfer.

Responsibilities

• Lead development projects from concept through commercialization for device/combination products.
• Develop and manage project plans with clear risks and milestones.
• Define device requirements including user needs and translate to verified/validated specs.
• Ensure compliance with FDA/ISO 13485 design controls and ISO 14971 risk management.
• Oversee human factors activities per FDA guidance and IEC 62366.
• Coordinate design transfer to manufacturing for scalable production.
• Collaborate with CMC, QA, Regulatory, Clinical, and Commercial teams.
• Prepare regulatory submissions (INDs, NDAs, BLAs) for devices.
• Manage vendor/CDMO relationships to meet quality/tech requirements.

Skills

Medical device development

Program leadership

Cross‑functional collaboration

Regulatory knowledge

Quality systems

Risk management

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Job description

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

You will drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust development aligned with patient needs and regulatory expectations.