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

AbbVie • North Chicago, IL

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About The Position

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. The role contributes to developing therapeutic drug-device combination products and aesthetic devices, including prefilled syringes, autoinjectors, connected and electromechanical drug delivery systems, eyecare products, and breast implants.

Working in a global, cross-functional team, the engineer integrates inputs and risks from multiple disciplines to support robust, patient-centric product design and performance. The role ensures development activities align with business objectives and global regulatory requirements while supporting efficient market access worldwide. It establishes working relationships across North America and Europe and may involve periodic travel, approximately 10% as necessary.

The role leads Design Control and Risk Management activities, translates evolving regulations and standards into practical development processes, develops compliance strategies for global registration and commercialization, and supports interactions with certification agencies and regulatory authorities. At this level, the engineer is also expected to improve development efficiency, compliance effectiveness, product quality, and organizational capability through strategic initiatives, training, knowledge-sharing, coaching, and mentoring.

Requirements

• Bachelor’s degree in Engineering, Science, or a related discipline and 14+ years of experience; or a master’s degree and 12+ years; or a PhD and 6+ years.
• 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 FDA 21 CFR Part 820, ISO 14971, ISO 13485, and EU MDR.
• Expertise in Systems Engineering, including user and stakeholder needs definition, requirements development, traceability, change management, and risk management.
• Expertise in Design History File (DHF) development, maintenance, and governance.
• Experience supporting internal and external audits, certification body assessments, and regulatory inspections.
• Experience translating complex regulatory requirements and industry standards into operational development processes.
• Strong analytical, decision-making, communication, and written communication skills, including technical documentation and compliance deliverables.
• Ability to influence without direct authority across cross-functional organizations.
• Experience leading technical initiatives involving external partners and suppliers.
• Ability to operate effectively in global and multicultural environments.
• Approximately 10% travel as necessary.

Nice To Haves

• 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.
• Demonstrated success developing training programs and communities of practice.
• Familiarity with electromechanical, connected, and software-enabled medical devices.
• Knowledge of IEC 62366, IEC 62304, and IEC 60601.

Responsibilities

• Implement product development engineering principles within the Design Controls process, with emphasis on Design Inputs, Risk Management, compliance governance, and systems integration.
• Define user and stakeholder needs and system requirements.
• Plan and report risk management in accordance with ISO 14971.
• Conduct system risk assessments and use error risk assessments.
• Maintain Design Control traceability.
• Translate evolving global regulations, standards, and guidance into practical Design Control and Risk Management processes.
• Develop and maintain compliance strategies supporting product registration and commercialization in global markets.
• Evaluate regulatory trends and emerging industry expectations to 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 decisions across technical and business stakeholders, balancing compliance, innovation, timelines, and business objectives.
• Identify opportunities to improve Design Control and Risk Management processes.
• Lead strategic initiatives to improve development efficiency, compliance effectiveness, and product quality.
• Develop organizational capabilities through training, knowledge-sharing, coaching, and mentoring.
• Foster continuous improvement, innovation, and technical excellence.
• Promote harmonized global approaches to compliance and systems engineering.
• Establish strong working relationships across North America and Europe.

Benefits

• Paid time off, including vacation, holidays, and sick time.
• Medical insurance.
• Dental insurance.
• Vision insurance.
• 401(k).
• Eligibility to participate in long-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal