Systems Engineering Manager

AbbVie-posted 3 months ago

Full-time • Manager

North Chicago, IL

Chemical Manufacturing

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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.

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.

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.

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

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

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