Sr. Systems Engineer
AbbVie
10 days ago
Remote friendly (North Chicago, IL)
United States
$109,500 - $208,500 USD yearly
IT
Sr. Systems Engineer (Combination Product Development)
Responsibilities:
- Lead user and stakeholder needs definition, use case analysis, traceability, standards coverage analysis, system/sub-system requirements definition, third-party development integration, system architecture & integration, risk management planning/reporting, system risk assessment, use error risk assessments, drug product development integration, and design validation.
- Broaden and apply appropriate systems engineering principles within AbbVie; activities may be performed internally and externally.
- Build relationships with external engineering service firms and third-party development partners (Europe, India, Asia, US), including periodic face-to-face visits.
- Provide technical leadership and ensure systems design/documentation meet safety and regulatory compliance requirements.
Qualifications:
- BS (typically 12 yrs) or MS (typically 10 yrs) or PhD (typically 4 yrs).
- Strong theoretical/practical understanding; effective writer/communicator of regulatory materials.
- Leadership experience influencing/negotiate internally and externally across global engineering teams.
- Full product development experience from initial concept through release to market.
- Expertise in regulated design/development standards: IEC 60601, ISO 14971, IEC 62304, 11608; compliance with ISO 13485, 21 CFR 820, MDR.
- Experience with user/stakeholder needs definition, requirements definition, risk management, product architecture.
- Knowledge of requirements management tools, V-model implementation, context/architecture diagrams, interface management; device design controls, system decomposition, operational simulations, error budgeting, sensitivity analysis.
- Experience with vendor communication/management and deliverable acceptance testing; technical leadership/ownership.
Benefits (if applicable): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.
Responsibilities:
- Lead user and stakeholder needs definition, use case analysis, traceability, standards coverage analysis, system/sub-system requirements definition, third-party development integration, system architecture & integration, risk management planning/reporting, system risk assessment, use error risk assessments, drug product development integration, and design validation.
- Broaden and apply appropriate systems engineering principles within AbbVie; activities may be performed internally and externally.
- Build relationships with external engineering service firms and third-party development partners (Europe, India, Asia, US), including periodic face-to-face visits.
- Provide technical leadership and ensure systems design/documentation meet safety and regulatory compliance requirements.
Qualifications:
- BS (typically 12 yrs) or MS (typically 10 yrs) or PhD (typically 4 yrs).
- Strong theoretical/practical understanding; effective writer/communicator of regulatory materials.
- Leadership experience influencing/negotiate internally and externally across global engineering teams.
- Full product development experience from initial concept through release to market.
- Expertise in regulated design/development standards: IEC 60601, ISO 14971, IEC 62304, 11608; compliance with ISO 13485, 21 CFR 820, MDR.
- Experience with user/stakeholder needs definition, requirements definition, risk management, product architecture.
- Knowledge of requirements management tools, V-model implementation, context/architecture diagrams, interface management; device design controls, system decomposition, operational simulations, error budgeting, sensitivity analysis.
- Experience with vendor communication/management and deliverable acceptance testing; technical leadership/ownership.
Benefits (if applicable): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.