Principal Systems Engineer, R&D Device & Combination Product Development

Job Description

AbbVie is seeking a Principal Systems Engineer to serve as a technical leader within R&D Device and Combination Product Development (DCPD), providing expertise in Systems Engineering, Compliance, Design Controls, and Risk Management. This individual will contribute to the development of innovative therapeutic drug-device combination products and aesthetic devices with technologies ranging from prefilled syringes and autoinjectors to connected and electromechanical drug delivery systems to eyecare products to breast implants.

This role will work in a global, cross functional team with the responsibility for the integration of inputs and risks from multiple disciplines to ensure robust patient-centric product design and performance. Technical expertise and leadership will be required to ensure that development activities align with both business objectives and global regulatory requirements while enabling efficient market access across worldwide regions.

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.
• Lead integration of Third-Party Development and Drug Product Development activities
• Serve as a subject matter expert during interactions with certification agencies and regulatory authorities.
• Facilitate decision-making across diverse technical and business stakeholders while balancing compliance, innovation, timelines, and business objectives.

At this level, significant contribution to raising the bar on how AbbVie develops combination products is expected. This includes:

• Identifying opportunities to generate innovative improvements in Design Control and Risk Management processes.
• Leading strategic initiatives focused on improving development efficiency, compliance effectiveness, and product quality.
• Driving organizational capability development through training, knowledge-sharing, coaching and mentoring.
• Foster a culture of continuous improvement, innovation, and technical excellence.
• Promote harmonized global approaches to compliance and systems engineering practices.

Qualifications

• BS in Engineering, Science, or related discipline with 14+ years of experience; OR MS in Engineering, Science, or related discipline with 12+ years of experience; OR PhD in Engineering, Science, or related discipline with 6+ years of experience.
• Demonstrated ability to resolve complex technical and compliance challenges through expert application of engineering principles and regulatory knowledge.
• Expertise in medical device and/or combination product development including strong knowledge of FDA 21 CFR Part 820, ISO 14971, ISO 13485, and EU MDR.
• Expertise in Systems Engineering principles, including:

• User and Stakeholder Needs definition
• Requirements development
• Traceability
• Change management
• Risk management

• Expertise in DHF development, maintenance, and governance.
• Experience supporting internal audits, external audits, certification body assessments, and regulatory inspections.
• Experience translating complex regulatory requirements and industry standards into operational development processes.
• Strong analytical, decision-making, and communication skills.
• Demonstrated ability to influence without direct authority across cross-functional organizations.
• Experience leading technical initiatives involving external partners and suppliers.
• Strong written communication skills, including development of technical documentation and compliance deliverables.
• Ability to effectively operate within global and multicultural environments.
• Active participation in AAMI, IEC Technical Committees, ISO Working Groups, AdvaMed, or similar industry organizations.
• Experience supporting global product registrations and regulatory submissions.
• Experience developing compliance governance frameworks, metrics, and performance indicators.
• Experience leading enterprise-wide Compliance, Design Control, or Risk Management improvement initiatives.

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