Systems Engineering Manager

AbbVie • North Chicago, IL

155d

About The Position

AbbVie is looking for a Systems Engineering Manager to join their Product Development Science and Technology Systems Engineering team to contribute to the development, launch, and maintenance of medical devices and drug/device combination products. As our Systems Engineering Manager you will be responsible for managing a team of Systems Engineers and integrating input from multiple disciplines to assure accurate and compliant Design History Files, and robust patient-centric product performance.

Requirements

• Management experience including managing internal and external engineering teams.
• Experience with identifying and deploying new methods and approaches within an organization.
• Experience with medical device or combination products including product requirements, DHF traceability, impact assessment, change management, risk management, and design validation.
• Familiarity with device design controls to enable new product introduction and lifecycle management.
• Strong problem solving, decision making, negotiation, and communication skills.

Nice To Haves

• Advanced degree in a technical field preferred.
• Post-graduate degree may contribute towards the desired years of experience.

Responsibilities

• Manage the accurate and compliant management of on-market Design History Files (DHF) for medical devices and combination products within the scope of systems engineering.
• Lead the team to ensure that all DHF documentation adheres to regulatory standards (e.g., FDA 21 CFR 820.30, ISO 13485, ISO 14971) and company procedures.
• Support product development, design changes, regulatory submissions, and audit readiness.
• Establish risk management files and design validation activities for new product introductions.
• Standardize and simplify systems engineering activities to enable more efficient development and marketed product support.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Participation in short-term incentive programs
• Participation in long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree