Senior Specialist, Drug/Device Combo Products Engineer - Hybrid

Merck•Rahway, NJ

2d•Hybrid

About The Position

This position is within the organization’s Device Development & Technology (DD&T) group in the 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, including products like injectors, inhalers, implants, infusion pumps, vaginal rings, and connected devices/apps. The role involves contributing to high-impact, complex, cross-functional, and cross-divisional teams and initiatives, providing input to achieve project goals, and collaborating effectively to meet company objectives. The group also supports commercially launched products. The company's DD&T Team is seeking a hands-on medical device product manufacturing and assembly engineer. This individual will be responsible for hands-on factory floor work and collaboration, interfacing with internal sites, medical device suppliers, and sub-suppliers. This includes working with small to large scale medical device assembly equipment suppliers, integrated manufacturing equipment component suppliers, and purchased device component suppliers. Additionally, the position requires interrogating device supplier processes as they relate to the company's combination product process specifications and critical quality attributes to support the combination product quality control strategy and preserve essential performance requirements.

Requirements

B.S. Degree in Mechanical, Electrical Engineering or related field with a minimum 6 years of regulated industry experience.
SME level knowledge of combination product assembly system vision inspection processes and development.
Experience with Cognex, Keyence or comparable vision systems, including identifying appropriate lensing, lighting, and integration of camera inspection systems on equipment.
Ability to develop vision jobs using Insight Explorer or comparable vision system development environments.
Competent in reading wiring diagrams and experience in debugging wiring issues on manufacturing equipment.
Knowledgeable in deciphering PLC programs (Ladder Logic (LD), Structured Text (ST), Function Block Diagram (FBD), Sequential Function Charts (SFC), and Instruction List (IL)) and ability to make some program changes.
Mechanical aptitude and troubleshooting skills.
Ability to work independently and hands-on in a laboratory setting and manufacturing floor setting, including fabricating and maintaining table-top assembly systems, low-volume assembly systems, and developing preventative maintenance plans.
Strong interpersonal skills with an ability to collaborate in a team environment.
Excellent oral and written communication skills.
High level work ethic.
Willingness to spend time on a manufacturing floor.
Combination Products
Detail-Oriented
Deviation Management
Device Development
Driving Continuous Improvement
Electrical Engineering
Ethical Compliance
Function Block
GMP Documentation
Injection Moldings
ISO 13485 Medical Devices
ISO 14971 Risk Management
Medical Device Manufacturing
Plastic Injection Moulding
Product Development
Product Lifecycle Management (PLM)
Prototyping
Quality Management Systems (QMS)
Risk Management
Root Cause Analysis (RCA)
Structured Text
Teamwork
Vision Systems
Working Independently

Nice To Haves

Knowledge of injection molding and assembly of plastic products including design for low and high-volume manufacturing and assembly.
CAD design, including knowledge of SOLIDWORKS and 3D printing.
Prototyping and ability to fabricate custom fixtures for assembly and testing.

Responsibilities

Contribute to high impact, complex, cross-functional, and cross-divisional teams and initiatives, providing input to achieve project goals.
Perform hands-on factory floor work and collaborate by interfacing with internal sites, medical device suppliers, and sub-suppliers.
Work with small to large scale medical device assembly equipment suppliers, integrated manufacturing equipment component suppliers, and purchased device component suppliers.
Interrogate device supplier processes as they relate to combination product process specifications and critical quality attributes to support quality control strategy and preserve essential performance requirements.
Develop vision jobs using Insight Explorer or comparable vision system development environments.
Debug wiring issues on manufacturing equipment.
Perform some PLC program changes.
Work independently and hands-on in a laboratory setting and manufacturing floor setting, including fabricating and maintaining table-top assembly systems, low-volume assembly systems, and developing preventative maintenance plans.
Support manufacturing of clinical supplies.