Associate Principal Engineer, Drug-Device Combination Products

Job Description

This position is in our organization's Device Development & Technology (DD&T) group in our 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 our company's goals/objectives. The group also plays a key role in supporting commercially launched products.

• Develop detailed plans and strategies for combination product assembly processes and equipment, and lead a technical team to deliver qualified processes and equipment for clinical or commercial use.
• Author design/process FMEAs 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 failure modes in relation to assembly processes.
• Communicate complex information clearly and concisely to partner group stakeholders.
• Apply mechanical aptitude and hands‑on troubleshooting skills in laboratory and manufacturing floor settings.
• Collaborate in a team environment and demonstrate strong interpersonal skills.
• Maintain a high level of work ethic.
• Support process and technology transfer to the company's manufacturing facilities.

Education Minimum Requirement:

• 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
• DFMEA
• Design Verification Testing
• Device Development
• Equipment Qualification
• Equipment Validations
• Machine Learning
• Manufacturing Operations
• Mechanical Engineering
• Mechanical Testing
• Medical Device Management
• Medical Device Manufacturing
• Medical Devices Design
• PFMEA
• QMS
• Risk Control
• Teamwork
• Technical Project Management
• Troubleshooting

• CAD design, including knowledge of SOLIDWORKS.
• 3D printing and the ability to prototype and fabricate custom fixtures for assembly and testing.
• CAD Modeling.

The salary range for this role is $ – $. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable.

Benefits include medical, dental, vision, other insurance benefits for employee and family, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.

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.