Senior Electromechanical Systems Engineer

Senior Electromechanical Systems Engineer

Abb Vie is looking for a Sr. 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. 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

In addition, you will be responsible for contributing to broadening the understanding and implementation of appropriate systems engineering principles within Abb Vie, developing and fostering relationships with external Engineering Services firms and third‑party development partners in Europe, India, Asia, and the US, and ensuring the systems design and documentation meet all safety 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 need definition; requirements definition; risk management; product architecture.
• Strong analytical and communication skills; experience with requirements management tools, V‑model implementation, context diagrams, architecture diagrams, and interface management.
• Familiarity with device design controls, system decomposition, operational simulations, error budgeting, sensitivity analysis.
• Strong analytical, decision‑making and communication skills; ability to create and manage project schedules and identify project risks and develop mitigation plans.

• Bachelor’s Degree or equivalent education; typically 12 years of experience, Master’s Degree or equivalent education; typically 10 years of experience, PhD; 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.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short‑term incentive programs.
• This job is eligible to participate in our long‑term incentive programs.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico only – to learn more, visit

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