Senior Specialist, Drug/Device Combo Products Engineer - Hybrid

Job Overview This position is within the Device Development & Technology (DD&T) group in our Research division. It supports the development of medical devices such as injectors, inhalers, implants, infusion pumps, vaginal rings, and connected devices from conception through launch. The role involves hands‑on factory floor work and collaboration with internal sites, medical device suppliers, and sub‑suppliers to ensure alignment with combination product process specifications and quality attributes. Education Minimum Requirement: B.S. Degree in Mechanical, Electrical Engineering, or a related field with a minimum of 6 years of regulated industry experience. Required Skills and Responsibilities Hands‑on manufacturing and assembly engineering, including fabrication and maintenance of low‑volume and table‑top assembly systems. Expertise in combination product assembly vision inspection systems, including Cognex, Keyence or comparable devices; experience with camera integration, lensing, lighting, and development of vision jobs using Insight Explorer or similar environments. Strong knowledge of wiring diagrams and experience troubleshooting wiring issues on manufacturing equipment. Deciphering PLC programs (Ladder Logic, Structured Text, Function Block Diagram, Sequential Function Charts, Instruction List) and making program changes as needed. Ability to engage in preventative maintenance planning and independent troubleshooting on the manufacturing floor. Excellent oral and written communication, strong interpersonal skills, and a high level of work ethic. Preferred Experience and Skills Knowledge of injection molding and plastic product assembly, including design for low and high‑volume manufacturing. CAD design experience with SOLIDWORKS and 3D printing; prototyping and fabrication of custom fixtures. Experience with GMP documentation, ISO 13485, ISO 14971, risk management, and root cause analysis. Background in medical device manufacturing, quality management systems, and continuous improvement. Benefits Medical, dental, vision, and other health insurance benefits. 401(k) retirement plan. Paid holidays, vacation, and compassionate/sick leave. Salary and Compensation Salary range: $117,000.00 – $184,200.00. Compensation may include annual bonus and long‑term incentive, if applicable. EEO 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 any other legally protected characteristic. Job Posting Information Job posting end date: May 19, 2026. #J-18808-Ljbffr MSD Malaysia