Systems Engineering Manager

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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.

Responsibilities:

Your engineering team is responsible for the accurate and compliant management of on-market Design History Files (DHFs) for medical devices and combination products within the scope of systems engineering. You are responsible to lead your 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, supporting product development, design changes, regulatory submissions, and audit readiness.  Your team will also support lead systems engineers to establish risk management files and design validation activities for new product introductions. 

In addition to product support, you will also be responsible to standardize and simplify systems engineering activities to enable more efficient development and marketed product support. 

Skills / Experience:

• Management experience is required that includes managing internal and external engineering teams. 
• Experience is required with identifying and deploying new methods and approaches within an organization. 
• Experience is required with medical device or combination products including: product requirements:  DHF traceability, impact