AbbVie Principal Systems Engineer at AbbVie providing technical leadership in R&D Device and Combination Product Development. Focus on Systems Engineering, Compliance, Design Controls, and Risk Management for drug-device combination products.
Responsibilities
This role will include implementation of product development engineering principles within the Design Controls process, with particular focus on Design Inputs, Risk Management, compliance governance, and systems integration. This role requires establishing strong working relationships across North America and Europe and may involve periodic travel.
This role will be responsible for driving the following activities and deliverables:
User and Stakeholder Needs Definition
System Requirements Definition
Risk Management Planning and reporting in accordance with ISO 14971
System Risk Assessment
Use Error Risk Assessments
Design Control Traceability
Additionally, this role will:
Translate evolving global regulations, standards, and guidance documents into practical Design Control and Risk Management processes that support efficient product development and enable global market access.
Develop and maintain compliance strategies that support product registration and commercialization in global markets.
Evaluate regulatory trends and emerging industry expectations to proactively strengthen Design Control and Risk Management practices.
