Associate Principal Engineer, Drug-Device Combination Products

$142.4k - $224.1k

Merck

Associate Principal Engineer position within Device Development & Technology group responsible for designing and developing drug-device combination products including autoinjectors, inhalers, and connected devices. The role involves hands-on manufacturing engineering, equipment development, and cross-functional collaboration with internal teams and external suppliers.

Responsibilities

Develop detailed plans and strategies for combination product assembly processes and equipment; lead technical delivery
Author design/process FMEAs and process validation protocols including IQ, OQ, PPQ documentation
Design and troubleshoot automated assembly equipment including vision systems, ultrasonic welding, and component handling
Manage manufacturing site readiness including equipment qualification and associated documentation requirements
Support process and technology transfer to company manufacturing facilities

Requirements

Bachelor's degree in Mechanical Engineering or related field
Minimum 15 years of regulated medical device industry experience
Expertise in combination product assembly process and equipment design
Proficiency with design/process FMEA and process validation documentation
Experience managing automated assembly equipment suppliers and processes
Knowledge of DFM/DFA principles and device failure mode analysis
Strong mechanical aptitude with hands-on troubleshooting and lab/floor skills

Compensation: $142,400 - $224,100

Apply

Vacancy posted 5 days ago

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