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Senior Scientist, Device Engineering

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Kailera Therapeutics

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Location:
United States , Waltham

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

115000.00 - 140000.00 USD / Year
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Job Description:

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 global standards and regulatory expectations.

Job Responsibility:

  • Lead the design and development of combination products, including autoinjectors, pre-filled syringes, and multidose pens, from concept through commercialization
  • Develop device and combination product requirements including user and stakeholder needs, 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
  • Manage risk management activities in accordance with ISO 14971, including hazard analysis, FMEA, and risk mitigation strategies
  • Drive design verification and validation activities, including test method development, protocol execution, and documentation
  • Oversee human factors and usability engineering efforts, ensuring compliance with FDA guidance and IEC 62366
  • Facilitate design transfer to manufacturing, ensuring smooth transition and scalability
  • Collaborate cross-functionally with clinical, regulatory, commercial, supply chain, and other key functions to ensure integration of device development activities
  • Author relevant portions of regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for devices and combination product programs
  • Manage and collaborate with vendors including Contract Design and Manufacturing Organizations (CDMOs), test vendors, and consultants to integrate deliverables into the project Design History File
  • Ensure product development aligns with relevant standards including ISO 11608-1, ISO 11040, ASTM D4169, ISO 14971, and IEC 62366

Requirements:

  • 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
  • Deep understanding of design controls, risk management, human factors, and design transfer
  • Strong knowledge of applicable regulatory standards and guidance documents
  • Excellent communication, leadership, and cross-functional collaboration skills
  • Bachelor’s degree in mechanical engineering, biomedical engineering, or related field with 12+ years of experience. Advanced degree with 10+ years of experience is preferred.

Nice to have:

  • Experience working in a regulated pharmaceutical or biotech environment
  • Familiarity with combination product regulations (21 CFR Part 4)
  • Experience with supplier management and external development and manufacturing partners
  • PMP certification or formal project management training is a plus
What we offer:
  • comprehensive health coverage
  • flexible time off
  • paid holidays
  • year-end shutdown
  • monthly wellness stipend
  • generous 401(k) match
  • tuition reimbursement
  • commuter benefits
  • disability and life insurance
  • annual bonus opportunities
  • equity grants

Additional Information:

Job Posted:
January 15, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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