Senior Engineer, Drug-Device Combination Products

Overview Position is in the Device Development & Technology (DD&T) group of the Research division. The group develops 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. Responsibilities Hands‑on factory floor work and collaboration with internal sites, medical device suppliers and sub‑suppliers. Interrogate device supplier processes related to combination product process specifications and critical quality attributes. Develop, implement and troubleshoot combination product assembly equipment processes, including vision systems, ultrasonic welding and automated component and glass feeding and handling systems. Author design/process FMEA to capture design‑related risks and identify appropriate risk controls. Design and author process validation activity and documentation such as IQ, OQ, PPQ, protocols and reports. Create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs. Apply device and combination product DFM/DFA principles and design/failure‑mode analysis in relation to assembly processes. Communicate complex information clearly to partner group stakeholders. Work independently in laboratory and manufacturing floor settings, troubleshooting mechanical issues. Collaborate in a team environment and support process and technology transfer to manufacturing facilities. Minimum Qualifications B.S. Degree in Mechanical Engineering or related field with a minimum of eight years of regulated industry experience. Strong mechanical aptitude and hands‑on troubleshooting skills. Excellent oral and written communication skills. Interpersonal and team collaboration abilities. High work ethic and ability to work independently. Preferred Experience and Skills CAD design experience, including SOLIDWORKS and 3D printing capability. Prototyping and fabrication of custom fixtures for assembly and testing. Analytical method development and method validation experience. Knowledge of ISO 13485, device manufacturing processes, and FDA regulations. Experience with ultrasonic welding and other automated assembly equipment. Risk control assessment, statistical analysis, and technical writing skills. Benefits Compensation range: $117,000.00 – $184,200.00, with eligibility for annual bonus and long‑term incentive if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity 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. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. Availability This position is open to San Francisco and Los Angeles residents only. The application deadline is stated on this posting. #J-18808-Ljbffr MSD Malaysia