Associate Principal Engineer, Drug-Device Combination Products

Overview

This position is in our organization's Device Development & Technology (DD&T) group within the Research division, responsible for developing devices, combination products, processes, testing, and assembly equipment from conception through product launch. As a hands‑on medical device product manufacturing and assembly engineer, you will perform factory‑floor work, collaborate with internal sites, suppliers, and sub‑suppliers, and interrogate device supplier processes to support our combination product quality control strategy and preserve essential performance requirements.

• B.S. Degree in Mechanical Engineering or a related field with a minimum of 15 years of regulated industry experience

• Develop detailed plans and strategies for combining product assembly processes and equipment development, and lead technical teams to deliver qualified processes and equipment for clinical or commercial use
• Author design/Process FMEA to capture design‑related risks and identify appropriate risk controls ensuring robust device functionality
• Design and author process validation activities and documentation such as IQ, OQ, PPQ, and other related reports
• Write protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs
• Design and set up automated combination product assembly equipment, including experience managing 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 related documentation
• Apply device and combination product DFM/DFA principles and assess failure modes related to assembly processes
• Communicate effectively, both orally and in writing, presenting complex information clearly and concisely to partner group stakeholders
• Demonstrate mechanical aptitude and hands‑on troubleshooting skills, working independently in laboratory and manufacturing floor settings
• Exhibit strong interpersonal skills to collaborate within a team environment and maintain a high level of work ethic
• Support process and technology transfer to our company's manufacturing facilities
• Utilize CAD design (SOLIDWORKS) and 3D printing to prototype and fabricate custom fixtures for assembly and testing

• Additional CAD modeling experience with a focus on combination products
• Knowledge of human‑factor engineering, machine learning, and medical device management
• Familiarity with design controls, design failure mode and effect analysis (DFMEA), design verification testing, and quality management systems (QMS)

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. If you need an accommodation during the application or hiring process, please . 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 Opport