Principal Systems Engineer, R&D Device & Combination Product Development
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 development of therapeutic drug-device combination products and aesthetic devices, including prefilled syringes, autoinjectors, connected and electromechanical drug delivery systems, eyecare products, and breast implants. Working on a global, cross-functional team, the Principal Systems Engineer integrates inputs and risks from multiple disciplines to support robust, patient-centric product design and performance. The role provides technical expertise and leadership to align development activities with business objectives and global regulatory requirements, while enabling efficient market access worldwide. It builds working relationships across North America and Europe and may involve periodic travel. The role translates global regulations, standards, and guidance into practical Design Control and Risk Management processes; develops compliance strategies for product registration and commercialization; and evaluates regulatory trends to strengthen practices. It leads integration of third-party development and drug product development activities, serves as a subject matter expert with certification agencies and regulatory authorities, and facilitates decisions among technical and business stakeholders. The position is expected to improve how AbbVie develops combination products by identifying process improvements, leading strategic initiatives, developing organizational capability through training and mentoring, promoting continuous improvement and technical excellence, and advancing harmonized global compliance and systems engineering practices.
Requirements
- Bachelor's degree in Engineering, Science, or a related discipline with 14+ years of experience; or a master's degree with 12+ years; or a PhD with 6+ years.
- Demonstrated ability to resolve complex technical and compliance challenges using 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, 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 regulatory requirements and industry standards into operational development processes.
- Strong analytical, decision-making, communication, and written communication skills, including technical documentation and compliance deliverables.
- Demonstrated 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, particularly for 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 that support 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 while 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 practices.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
