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 and initiatives, and will provide input to achieve project goals.

Effective collaboration with teams is essential to meet our company’s goals and 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, interfacing with internal sites, medical device suppliers and sub‑suppliers. It includes working with small to large scale medical device assembly equipment suppliers, integrated manufacturing equipment component suppliers and purchased device component suppliers. In addition, the engineer shall interrogate device supplier processes as they relate to our combination product process specifications and critical quality attributes to support our combination product quality control strategy and preserve essential performance 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 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 performing some program changes.
• Mechanical aptitude and troubleshooting skills, with the ability to work independently and hands‑on in a laboratory and manufacturing floor setting, including fabricating and maintaining table‑top assembly systems, low‑volume assembly systems, and developing preventative maintenance plans.
• Strong interpersonal skills and 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.

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

• 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

U.S. and Puerto Rico Residents Only.

U.S. Hybrid Work Model:
Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid model consisting of three total days on‑site per week (Monday–Thursday), with Friday designated as a remote‑working day, unless business critical tasks require on‑site presence. This model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions where…