Principal Systems Engineer, Medical Device & Combo Products
AbbVie Inc.
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Job summary
AbbVie Inc. is seeking a Principal Systems Engineer for R&D Device & Combination Product Development to lead technical activities in design controls, risk management, and regulatory alignment on a global scale.
You will collaborate with cross-functional teams across NA and Europe, travel ~10%, and drive substantial improvements in development efficiency and product quality. The role requires extensive experience in medical device/combo product development, strong regulatory knowledge, and proven
Qualifications
- Knowledge of medical device and/or combination product development.
- FDA 21 CFR Part 820, ISO 14971, ISO 13485, EU MDR familiarity.
- Systems Engineering lifecycle and design controls.
- Risk management and DHF governance.
Responsibilities
- User and Stakeholder Needs Definition
- System Requirements Definition
- Risk Management Planning and reporting per ISO 14971
- Translate regulations into Design Control and Risk Management processes
- Develop and maintain global compliance strategies
- Lead integration of Third-Party Development and Drug Product Development
- Serve as SME with certification bodies/regulatory authorities
- Facilitate decision-making across diverse stakeholders
Skills
Education
Job description
AbbVie Inc. is seeking a Principal Systems Engineer for R&D Device & Combination Product Development to lead technical activities in design controls, risk management, and regulatory alignment on a global scale.
You will collaborate with cross-functional teams across NA and Europe, travel ~10%, and drive substantial improvements in development efficiency and product quality. The role requires extensive experience in medical device/combo product development, strong regulatory knowledge, and proven
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