Senior Principal Systems Engineer

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This range is provided by Abb Vie. Your actual pay will be based on your skills and experience – talk with your recruiter to learn more.

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Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Purpose: Abb Vie is looking for a Sr. Principal Systems Engineer to join their Combination Product Development team. This individual will contribute to the development and launch of exciting new drug / device combination products.

As a Sr. Principal Systems Engineer, you will be responsible for the integration of multiple disciplines to ensure robust patient‑centric product design and performance.

• 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
• Design Validation
• Providing technical leadership, ensuring systems design and documentation meet safety, quality and regulatory compliance requirements

• Leadership experience that includes the ability to influence and negotiate internally and externally as part of global engineering teams.
• Experience through full product development from initial concept to release to market.
• 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 with ISO 13485, 21 CFR 820 and MDR.
• Experience in user and stakeholder needs definition; requirements definition; risk management; system architecture.
• Strong analytical and communication skills, and familiarity with requirement management tools, V‑model implementation, context and architecture diagrams, and interface management.
• Familiarity with device design controls, system decomposition, operational simulations, error budgeting, and sensitivity analysis.
• Strong decision‑making, communication (spoken and written) skills, project schedule creation, risk assessment and mitigation planning.
• Experience interfacing with 3rd‑party vendors, vendor communication, management, deliverable acceptance testing, and multi‑cultural awareness.
• Demonstrated technical leadership and ownership, with guidance to less experienced technical personnel.
• Strong technical knowledge and application of concepts, practices, and procedures for complex problems.
• Active contribution to innovation initiatives, coaching/training, and identifying improvement opportunities.
• Travel will be required, as necessary (10%).

• 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.

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
  
  This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation,…