Associate Principal Engineer, Drug-Device Combination Products

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.

Our company's DD&T Team is seeking a hands-on medical device product manufacturing and assembly engineer. This position will be responsible for hands-on factory floor work and collaboration, via interfacing with our company's internal sites, medical device suppliers and sub-suppliers. This includes working with both small to large scale medical device assembly equipment suppliers, integrated manufacturing equipment component suppliers and purchased device component suppliers. In addition, this position shall interrogate device supplier processes as they relate to our company's combination product process specifications and critical quality attributes to support our company's combination product quality control strategy and preserve essential performance requirements.

Education Minimum Requirement:

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

Required skills and key responsibilities for this position include:

• Can develop detailed plans and strategies for combination of product assembly process and equipment development and lead 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

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

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Required Skills:

Assembly Language (ASM), Assembly Language (ASM), Assembly Processes, CAPA Management, Combination Products, Component Development, Cultural Diversity, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design for Assembly (DFA), Design for Manufacturing (DFM), Design Verification Testing, Device Design, Diversity Awareness, Documentation Preparation, Engineering Document Management, Engineering Support, Equipment Designing, Equipment Engineering, Fixtures Design, Human Factor Engineering, Manufacturing Strategies, Mechanical Testing, Medical Device Manufacturing, Medical Device Quality Systems {+ 9 more}