Principal Systems Engineer, R&D Device & Combination Product Development
AbbVie
AbbVie seeks a Principal Systems Engineer to lead R&D Device and Combination Product Development, ensuring robust design controls, risk management, and regulatory compliance across drug-device combination products and aesthetic devices. This technical leadership role requires expertise in systems engineering, medical device standards, and global regulatory strategy to drive efficient product development and market access.
Responsibilities
- Drive Design Controls implementation focusing on design inputs, risk management, and systems integration
- Develop user/stakeholder needs definitions and system requirements; plan and execute risk assessments per ISO 14971
- Translate evolving global regulations and standards into practical compliance and design control processes
- Lead integration of third-party and drug product development activities; serve as subject matter expert for regulatory interactions
- Identify and champion strategic initiatives to improve development efficiency, compliance effectiveness, and organizational capability
Requirements
- Bachelor's in Engineering/Science with 14+ years experience, OR Master's with 12+ years, OR PhD with 6+ years
- Expertise in FDA 21 CFR Part 820, ISO 14971, ISO 13485, and EU MDR regulations
- Advanced knowledge of systems engineering principles including requirements development, traceability, and risk management
- Demonstrated proficiency in Design History File (DHF) development, maintenance, and governance
- Experience translating complex regulatory requirements into operational development processes
- Strong cross-functional influence and communication skills across global, multicultural organizations
- Experience with medical device audits, certifications, and regulatory inspections
Vacancy posted 1 day ago
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