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

Merck Sharp & Dohme Corp

New Jersey, United States
Base: $139,600.00 - $219,700.00; bonus/equity: ann...
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Mechanical engineering degree with experience
8 years combination product development
Design verification strategy execution
** Merck Sharp & Dohme Corp is seeking an Associate Principal Scientist in Combination Product Design Verification to lead design verification testing strategies for drug-device combination products. The role requires extensive experience in product development, collaboration across functions, and a strong understanding of regulatory standards. **

Job Summary

  • This role leads the definition and execution of design verification strategies for innovative biologic/drug/vaccine-device combination products.
  • The successful candidate will author and review regulatory submissions including INDs, IMPDs, NDAs, and BLAs for combination product programs.
  • Employees in this office-based position work a hybrid model consisting of three days on-site per week with Friday designated as remote.

Matching Summary

Match Score: 75

** Merck Sharp & Dohme Corp is seeking an Associate Principal Scientist in Combination Product Design Verification to lead design verification testing strategies for drug-device combination products. The role requires extensive experience in product development, collaboration across functions, and a strong understanding of regulatory standards. **

Salary

Base: $139,600.00 - $219,700.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • Mechanical Engineering degree with experience
  • 8 years combination product development
  • Design verification strategy execution
  • ISO 11608 ISO 14971 regulatory knowledge
  • Test method development and validation
  • Cross-functional team leadership

Nice-to-have

  • Experience with electro-mechanical sub-assemblies
  • Analytical or numerical simulation skills
  • 3D CAD and rapid manufacturing techniques
  • Eagerness to identify lab capability gaps
  • Strong collaboration and ideation skills

Key Requirements

  • B.S. Mechanical Engineering + 8 years experience
  • M.S. Mechanical Engineering + 5 years experience
  • Ph.D. Mechanical Engineering + 3 years experience
  • Leadership of design verification programs
  • Comprehensive knowledge of device development interdependencies

Work Rights

Not specified

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