Senior Specialist, Drug​/Device Combo Products Engineer - Hybrid

Job Overview

This role is located in the Device Development & Technology (DD&T) group within the Research division. The DD&T group develops devices, combination products, processes, and testing/assembly equipment from conception to product launch, including injectors, inhalers, implants, infusion pumps, vaginal rings, and connected devices/apps. The position supports high‑impact, cross‑functional teams and collaborates closely with internal sites, medical device suppliers and sub‑suppliers.

• Perform hands‑on factory floor work and collaborate with manufacturing and supply‑chain partners.
• Interact with medical device assembly equipment suppliers ranging from small to large scale.
• Interface with integrated manufacturing equipment component suppliers and purchased device component suppliers.
• Interrogate device supplier processes relative to combination product process specifications and critical quality attributes to support the company’s quality control strategy.
• Develop and maintain vision inspection systems, including lensing, lighting, and camera integration using Cognex, Keyence or similar systems.
• Create vision jobs in Insight Explorer or comparable development environments.
• Read and debug wiring diagrams and PLC programs (Ladder Logic, Structured Text, Function Block Diagram, Sequential Function Charts, Instruction List) and implement necessary program changes.
• Troubleshoot mechanical and electrical issues, fabricate and maintain laboratory and manufacturing floor assembly systems, and develop preventive maintenance plans.
• Provide strong interpersonal collaboration, excellent communication, and a high level of work ethic.
• Support clinical supplies manufacturing and maintain presence on the manufacturing floor.

• B.S. Degree in Mechanical, Electrical Engineering or a related field.
• Minimum 6 years of regulated‑industry experience.
• SME knowledge of combination product assembly system vision inspection processes and development.
• Experience with Cognex, Keyence or comparable vision systems.
• Proficiency in developing vision jobs with Insight Explorer or similar platforms.
• Competence in reading wiring diagrams and debugging manufacturing equipment.
• Familiarity with PLC programming languages and ability to modify programs.
• Mechanical aptitude, troubleshooting skills, and ability to work independently on lab and manufacturing floor.
• Strong interpersonal, written and oral communication skills.
• Willingness to spend time on the manufacturing floor and support clinical supplies production.

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

Combination Products, Detail‑Oriented, Deviation Management, GMP Documentation, ISO 13485, ISO 14971, Medical Device Manufacturing, Product Lifecycle Management, Vision Systems, Structured Text, Teamwork, Ethical Compliance.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.

The position follows a hybrid work model. Employees in office‑based roles in the U.S. will work a hybrid schedule 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, manufacturing‑based, research‑based, or other positions that require daily in‑person attendance.

Salary range: $ – $. Additional annual bonus and long‑term incentive opportunities may apply.

Comprehensive benefits package including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.

• Employee Status:
  Regular
• Relocation:
  Domestic
• VISA Sponsorship:
  No
• Travel Requirements: 10%
• Shift: 1st – Day
• Valid Driving License:
  Yes
• Hazardous Material(s):
  No
• Job Posting End Date: 05/19/2026