Associate Principal Engineer – Drug‑Device Combination Products

About the role

The Associate Principal Engineer will work within Merck's Device Development & Technology group, focusing on the design, development, and qualification of combination product assembly processes and equipment for clinical and commercial use.

Key responsibilities

• Develop detailed plans and strategies for combination product assembly process and equipment, leading technical teams to deliver qualified solutions.
• Author design and process FMEAs, process validation protocols (IQ, OQ, PPQ), and related documentation.
• Design and qualify automated assembly equipment, including vision systems, ultrasonic welding, and automated feeding mechanisms.
• Manage equipment supplier relationships and ensure compliance with combination product specifications and quality attributes.

Required profile

• B.S. in Mechanical Engineering or related field with at least 15 years of regulated industry experience.
• Proven experience in hands‑on factory floor work, equipment qualification, and cross‑functional collaboration.
• Strong oral and written communication skills with the ability to present complex technical information.

Required skills

• Mechanical Engineering expertise
• Combination product assembly and equipment design
• FMEA and CAPA management
• Process validation (IQ, OQ, PPQ)
• CAD design using SOLIDWORKS and 3D printing
• Vision systems, ultrasonic welding, automated component feeding
• Design for Manufacturing (DFM) and Design for Assembly (DFA)

What we offer

• Salary range $142,400 – $224,100 per year
• Annual bonus and long‑term incentive eligibility
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation and sick days