AbbVie is looking for a Systems Engineering Manager to manage a team of Systems Engineers and integrate input from multiple disciplines to assure accurate and compliant Design History Files, and robust patient-centric product performance for medical devices and drug/device combination products.
Requirements
- Experience is required with medical device or combination products including: product requirements: DHF traceability, impact assessment, and change management, risk management, and design validation.
- The candidate must be familiar with device design controls, to enable new product introduction and lifecycle management.
Responsibilities
- 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.
- accurate and compliant management of on-market Design History Files (DHFs) for medical devices and combination products within the scope of systems engineering.
- 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.
- support lead systems engineers to 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.
- identify and lead continuous improvement initiatives within systems engineering and the broader combination product organization to improve compliance, operational efficiency with product development and lifecycle management.
- interfacing with 3rd party vendors.
Other
- 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.
- strong problem solving, decision making, negotiation, and communication (spoken and written) skills.
- Travel will be required, as necessary. (10%)
- Business acumen coupled with leadership experience is required to drive high performance.
