Associate Principal Engineer, Drug-Device Combination Products

Merck • Rahway, NJ

1d • $142,400 - $224,100 • 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. Degree in Mechanical Engineering or related field with a minimum 15 years of regulated industry experience
• CAD Modeling
• Combination Products
• Computer-Aided Design (CAD)
• Design Controls
• Design Failure Mode and Effect Analysis (DFMEA)
• Design Verification Testing
• Device Development
• Human Factor Engineering
• Machine Learning (ML)
• Medical Device Management
• Medical Device Manufacturing
• Medical Device Quality Systems
• Medical Devices Design
• Quality Management Systems (QMS)
• Risk Control
• Test Method Validation

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
• Current Employees apply HERE
• Current Contingent Workers apply HERE
• US and Puerto Rico Residents Only:
• San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
• Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior