Senior Principal Systems Engineer jobs in United States
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AbbVie · 3 weeks ago

Senior Principal Systems Engineer

AbbVie is a company dedicated to discovering and delivering innovative medicines and solutions. They are seeking a Senior Principal Systems Engineer to contribute to the development and launch of drug/device combination products, ensuring robust patient-centric product design and performance through integration of multiple disciplines.

BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

You will be responsible for working across engineering teams to lead and drive the following:
User and Stakeholder Needs Definition
System Architecture & Integration
Use Case Analysis
Traceability
Standards Coverage Analysis
Risk Management Planning and reporting
System Risk Assessment
Use Error Risk Assessments
System/Sub-System Requirements Definition
Integration of Third-Party Development activities
Integration of Drug Product Development activities
In addition, you will be responsible for contributing to broadening the understanding and implementation of appropriate systems engineering principles within AbbVie. It is expected that the systems engineering activities for which you will be responsible may be done internally and externally. The external systems engineering activities will require you to develop and foster relationships with these external Engineering Services firms and third-party development partners who may be in Europe, India, Asia, and US, and in addition to regular teleconferences, will require periodic face-to-face visits
You will be responsible for providing technical leadership in your areas of responsibility and ensure the systems design and documentation meet all safety, quality and regulatory compliance requirements

Qualification

Systems EngineeringRisk ManagementProduct DevelopmentRegulatory ComplianceRequirements Management ToolsDevice Design ControlsLeadership ExperienceAnalytical SkillsVendor ManagementCommunication Skills

Required

Bachelor's Degree or equivalent education and typically 12 years of experience, Master's Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience
Possess thorough theoretical and practical understanding of own scientific discipline
Effective writer and communicator of research or other regulatory materials

Preferred

Leadership experience is required that includes the ability to influence and negotiate internally and externally as a part of global engineering teams
Experience through full product development from initial concept to release to market is required
Expertise in design and development processes that conform to standards including IEC 60601, ISO 14971, IEC 62304, 11608, and the ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and MDR
Experience is required in user and stakeholder needs definition; requirements definition; risk management, system architecture
The candidate must have strong analytical and communication skills
Experience with requirements management tools, V-model implementation, context diagrams, architecture diagrams, and interface management
The candidate should be familiar with device design controls, system decomposition, operational simulations, error budgeting, sensitivity analysis
Other attributes include strong analytical, decision making and communication (spoken and written) skills
Experience in vendor communication, management, deliverable acceptance testing and multi-cultural awareness
Must have demonstrated technical leadership and ownership, and the ability to provide guidance and direction to less experienced technical personnel
Possesses a strong technical knowledge and application of concepts, practices, and procedures
It is expected at this level that you will contribute to raising the bar to how we execute in combination product development
This includes the identification and leadership of improvement initiatives, coaching / training individuals, looking for new ideas to stimulate innovation and connect unrelated concepts, generating original or unique ideas
Travel will be required, as necessary. (10%)

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-term incentive programs

Company

AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.

H1B Sponsorship

AbbVie has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)

Funding

Current Stage
Public Company
Total Funding
$15B
2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO

Leadership Team

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Robert Michael
Chairman of the Board and Chief Executive Officer
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Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
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Company data provided by crunchbase