Associate Principal Engineer, Drug-Device Combination Products

Merck•Rahway, NJ

2d•Hybrid

About The Position

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.

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.
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

Nice To Haves

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

Responsibilities

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