Associate Director, Device Engineering

Kailera

Waltham, MA, USA
Base: $159,000 - $195,000 usd; bonus/equity: annua...
On-site (3-4 days per week)
Drug-device combination products
Autoinjectors, pre-filled syringes, multidose pens
Design controls per fda and iso 13485
Kailera is seeking an Associate Director of Device Engineering to lead the development and launch of drug-device combination products, particularly focusing on autoinjectors, pre-filled syringes, and multidose pens. The role requires significant experience in medical device development, strong leadership skills, and the ability to navigate regulatory standards

Job Summary

  • Lead the development and launch of drug-device combination products, with a strong emphasis on autoinjectors, pre-filled syringes, and multidose pens.
  • Drive cross-functional collaboration across CMC, quality, regulatory, manufacturing, clinical, and commercial teams to ensure robust product development.
  • Manage and collaborate with vendors, including Contract Design and Manufacturing Organizations (CDMOs) and suppliers, to ensure components and products meet quality and technical requirements.

Matching Summary

Match Score: 85

Kailera is seeking an Associate Director of Device Engineering to lead the development and launch of drug-device combination products, particularly focusing on autoinjectors, pre-filled syringes, and multidose pens. The role requires significant experience in medical device development, strong leadership skills, and the ability to navigate regulatory standards.

Salary

Base: $159,000 - $195,000 USD; Bonus/Equity: annual bonus opportunities and equity grants; Benefits: comprehensive health coverage, flexible time off, paid holidays, year-end shutdown, wellness stipend, 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance

Skills & Requirements

Must-have

  • drug-device combination products
  • autoinjectors, pre-filled syringes, multidose pens
  • design controls per FDA and ISO 13485
  • risk management in accordance with ISO 14971
  • human factors and usability engineering
  • design transfer to manufacturing
  • vendor management (CDMOs, suppliers)

Nice-to-have

  • entrepreneurial spirit
  • team-oriented culture
  • collaboration, integrity, excellence
  • diverse backgrounds, cultures, perspectives

Key Requirements

  • 10+ years medical device or combination product development
  • 3+ years team leadership role
  • Experience with autoinjector, pre-filled syringe, or multidose pen development and launch
  • Authoring clinical and commercial regulatory submissions
  • Deep understanding of design controls, verification, risk management, human factors, design transfer
  • Strong knowledge of applicable regulatory standards and guidance documents
  • Bachelor’s degree in mechanical engineering, Biomedical Engineering, or related field

Work Rights

Not specified

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