Associate Principal Engineer, Drug-Device Combination Products

Job Overview This position is in our organization’s Device Development & Technology (DD&T) group in the Research division. The 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, initiatives, and will provide input to achieve project goals. Effective collaboration with teams is essential to meet the company’s goals and objectives. The group also plays a key role in supporting commercially launched products. Responsibilities Develop detailed plans and strategies for combination product assembly processes and equipment development, and lead a technical team to deliver qualified processes and equipment for clinical or commercial use. Author design or process FMEA to capture design‑related risks and identify appropriate risk controls to ensure robust and efficient 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 associated documentation. Apply understanding of device and combination product DFM/DFA principles and design/ failure modes in relation to assembly processes. Communicate orally and in writing, presenting complex information clearly to partner group stakeholders. Apply mechanical aptitude and troubleshooting skills, working independently in both laboratory and manufacturing settings. Collaborate effectively within a team environment. Maintain a high level of work ethic. Support process and technology transfer to the company’s manufacturing facilities. Engage in hands‑on factory floor work and collaborate with internal sites, medical device suppliers and sub‑suppliers. Education Requirements B.S. in Mechanical Engineering (or related field) with 10+ years of regulated industry experience and increasing responsibility in medical devices and/or drug‑device combination products. Required Skills Accountability Combination Products Data Analysis Design Controls Design Failure Mode and Effect Analysis (DFMEA) Design Verification Testing Device Development Equipment Qualification Equipment Validations Machine Learning (ML) Manufacturing Operations Mechanical Engineering Mechanical Testing Medical Device Management Medical Device Manufacturing Medical Devices Design Process Failure Mode Effects Analysis (PFMEA) Quality Management Systems (QMS) Risk Control Teamwork Technical Project Management Troubleshooting 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 CAD Modeling Compensation and Benefits Salary Range: $142,400.00 - $224,100.00. Eligible for annual bonus and long‑term incentive, if applicable. 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. Location and Eligibility US and Puerto Rico residents only. San Francisco residents only: qualified applicants with arrest and conviction records will be considered. Los Angeles residents only: qualified applicants, including those with criminal histories, will be considered in compliance with local laws. Equal Employment Opportunity 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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement, and Learn more about your rights, including under California, Colorado and other US State Acts. We are proud to be a company that embraces diversity and inclusivity. #J-18808-Ljbffr Merck