Senior Specialist, Drug/Device Combo Products Engineer - Hybrid

Job Description

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 injectors, 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, Electrical Engineering or related field with a minimum 6 years of regulated industry experience.

Required skills and key responsibilities for this position include:

• SME level knowledge of combination product assembly system vision inspection processes and development.

• Has worked with Cognex, Keyence or comparable vision systems with experience in identifying appropriate lensing, lighting and integration of camera inspection systems on equipment

• Able to develop vision jobs using Insight Explorer or comparable vision system development environments

• Competent in reading wiring diagrams and has 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 can do some program changes

• Mechanical aptitude and troubleshooting skills, with the ability to work independently and hands-on in a laboratory setting and manufacturing floor setting including ability to fabricate and maintain table-top assembly systems, low-volume assembly systems, and development of 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

• Support manufacturing of clinical supplies and willingness to spend time on a manufacturing floor

Preferred Experience and Skills:  

• 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.

Required Skills:

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

Preferred Skills:

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US and Puerto Rico Residents Only:

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