Associate Principal Engineer, Drug-Device Combination Products

Job Description This position is in our organization’s Device Development & Technology (DD&T) group in our Research division. Our organization’s DD&T group is responsible for the development of devices, combination products, processes, testing and assembly equipment from conception through product launch. Products include autoinjectors, inhalers, implants, infusion pumps, vaginal rings and connected devices/apps. The person in this position contributes to high‑impact, complex, cross‑functional and cross‑divisional teams and initiatives, and will provide input to achieve project goals. Effective collaboration with teams is essential to meet our company’s goals/objectives. The group also plays a key role in supporting commercially launched products. Education Minimum Requirement B.S. Degree in Mechanical Engineering or a related field with a minimum of 15 years of regulated industry experience. Key Responsibilities Develop detailed plans and strategies for combination product assembly process and equipment development, and lead a technical team to deliver a qualified process and equipment for clinical or commercial use. Author design/process FMEA to capture risks and identify appropriate risk controls, ensuring robust device functionality. Design and author process validation activities and documentation such as IQ, OQ, PPQ, etc. Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs. Design automated combination product assembly equipment, and manage equipment suppliers. Develop, implement, and troubleshoot combination product assembly equipment processes, including vision systems, ultrasonic welding, and automated component and glass feeding and handling systems. Manage all aspects of manufacturing site readiness, including equipment qualification requirements and all associated documentation. Apply understanding of device and combination product DFM/DFA principles and failure modes in relation to assembly processes. Communicate complex information clearly to partner group stakeholders. Provide mechanical aptitude and hands‑on troubleshooting skills for laboratory and manufacturing floor settings. Collaborate effectively in a team environment. Maintain a high level of work ethic and support process and technology transfer to our company’s manufacturing facilities. Preferred Experience and Skills CAD design, including knowledge of SOLIDWORKS. 3D printing and the ability to prototype and fabricate custom fixtures for assembly and testing. Required Skills CAD Modeling, Combination Products, Computer‑Aided Design (CAD), Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design Verification Testing, Device Development, Human Factor Engineering, Machine Learning (ML), Medical Device Management, Medical Device Manufacturing, Medical Device Quality Systems, Medical Devices Design, Quality Management Systems (QMS), Risk Control, Test Method Validation. Preferred Skills Additional skill keywords such as Medical Device Manufacturing , Risk Management , Quality Systems , etc. Benefits & Compensation Salary range: $142,400.00 – $224,100.00. Comprehensive benefits include medical, dental, vision healthcare and other insurance benefits for employee and family, retirement benefits (including 401(k)), paid holidays, vacation, and compassionate and sick days. EEO and Inclusion Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. Location San Francisco Residents Only: Consideration for qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: Consideration for qualified applicants, including those with criminal histories, in accordance with the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Administrative Details Employee Status: Regular Relocation: Domestic Visa Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): None Job Posting End Date: 08/15/2026 #J-18808-Ljbffr Merck