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Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)

Merck · Rahway, NJ

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ResearchFull-time$142k–$224kCompany career page

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Role summary

Merck seeks an Associate Principal Scientist to lead design verification strategies for drug-device combination products across the development and commercialization lifecycle. This role provides technical and project leadership for testing strategy definition, execution, and regulatory support across inhalation, implantation, and injection delivery systems.

What they're looking for

  • B.S. in Mechanical Engineering or equivalent plus 8 years combination product development experience
  • M.S. in Mechanical Engineering or equivalent plus 5 years combination product development experience
  • Ph.D. in Mechanical Engineering or equivalent plus 3 years combination product development experience
  • Leadership experience directing design verification programs and cross-functional project teams
  • Knowledge of design controls, risk management, materials, molding, process development and validation
  • Experience with test method development, validation, stability studies, and process validation activities
  • Ability to influence across organizational levels and engage external partners effectively

What you'll be doing

  • Lead design verification strategy definition, execution, and stakeholder alignment for assigned combination product programs
  • Define design inputs/outputs and oversee design verification plans, protocols, and reports demonstrating compliance
  • Develop and validate test methodologies internally or with external partners per verification strategy
  • Direct accelerated and real-time aging studies, bridging studies, and stability testing across device components and assemblies
  • Establish testing protocols for process validation, shipping studies, and release testing at component and product levels

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