Associate Principal Engineer, Drug-Device Combination Products

Job Overview 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, 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. Key Responsibilities & Skills Can 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 design related risks and identify appropriate risk controls to ensure robust and efficient device functionality. Design and author Process validation activity and documentation like IQ, OQ, PPQ etc. Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs. Experience in designing automated combination product assembly equipment and experience in managing equipment suppliers. Experience in developing, implementing and troubleshooting combination product assembly equipment processes including vision systems, ultrasonic welding and automated component and glass feeding and handling systems. Experience and the ability to manage all aspects of manufacturing site readiness including equipment qualification requirements and all associated documentation. Understanding of device and combination product DFM/DFA principles and design and failure modes in relation to assembly processes. Excellent oral and written communication skills and the ability to present complex information in a clear and concise manner to partner group stakeholders. Mechanical aptitude and hands‑on troubleshooting skills, with the ability to work independently in a laboratory setting and manufacturing floor setting. Strong interpersonal skills with an ability to collaborate in a team environment. High level work ethic. Support process and technology transfer to our company’s manufacturing facilities. Education & Minimum 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. Preferred Experience and Skills CAD design, including knowledge of SOLIDWORKS and 3D printing and the ability to prototype and fabricate custom fixtures for assembly and testing. 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 Skills CAD Modeling Salary & Benefits Salary range: $142,400.00 – $224,100.00 Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive package: medical, dental, vision healthcare and other insurance benefits for employee and family; retirement benefits including 401(k); paid holidays, vacation, compassionate and sick days. Equal Employment Opportunity Statement We are committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. 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. We are proud to be a company that embraces the value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. #J-18808-Ljbffr Dormont Manufacturing Co