Advisor - Systems Engineering

About the role

The Advisor - Systems Engineer within DDCS supports the design, development, and commercialization of drug products and pharmaceutical delivery systems, including medical devices, device constituents of combination products, and container closure systems. This role integrates technical disciplines and collaborates with various functions to ensure the success of medical device projects.

Responsibilities

• Elicit needs and requirements from stakeholders; create, allocate, and manage system requirements; collaborate with technical functions to create subsystem and interface requirements; create and manage requirements traceability to system risk, verification, and validation.
• Responsible and accountable for system level design inputs, outputs, risk, and evidence throughout the development process; design/develop system architectures that incorporate flexibility, adaptability, modularity, and scalability to maximize reuse and interoperability/integration, applying cross-functional and external technical knowledge to drive data-driven architecture decisions.
• Develop, coordinate, and document the system test strategy and lead system integration, verification, and validation activities.
• Identify system hazards and perform system risk identification, assessment, and management; independently identify critical systems engineering issues affecting program delivery and proactively manage risk with an end-in-mind approach to minimize schedule and scope impact.
• Provide guidance, coaching, mentoring, and/or training to Systems Engineers and Technical Leads within their function or program team; may support a Technical Lead role on complex programs, contributing to technical accountability for successful delivery of the solution.
• Build and sustain a diverse, cross-functional and external network — spanning technical, clinical, regulatory, and business disciplines — to bring forward the best ideas and create an environment where team members feel safe to contribute.
• Drive continuous process improvement with a specific focus on systems engineering related processes; demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicating appropriately.

Requirements

• Earned Bachelor's degree in a Science, Technology, Engineering, or Math (STEM) field
• 10+ years of relevant experience
• Demonstrated experience and in-depth knowledge of systems engineering in one or more of the following areas: requirements elicitation/development/traceability/management/allocation, interface definition and management, system architecture development, enterprise architectures, technical planning and risk assessments, system level risk assessments (patient safety), trade-offs, system modeling and simulation, system integration, verification and validation planning and execution, model-based systems engineering (MBSE)
• Experience in systems engineering specifically with regard to medical devices or combination products
• Excellent written and verbal communication; able to establish and maintain strong working relationships with all levels of the internal organization across multiple functions and disciplines as well as with external suppliers, stakeholders, partners; capable of translating complex technical information into executive level communications

Qualifications

• Advanced degree in a Science, Technology, Engineering, or Math (STEM) field
• Familiar with FDA class II or III medical device regulatory requirements with knowledge of drug product and medical device standards (i.e. cGMP, 21 CFR 820, ISO 13485, IEC 60601, ISO 11608, ISO 14971, IEC 62366, etc.)
• Familiar with, or experience creating medical devices as a platform
• Prior leadership or supervisory experience managing complex programs, systems engineering tasks, or multi-functional teams; works effectively across boundaries, effectively influences without authority, excels in a highly collaborative environment
• Previous organizational change management experience

Basic Qualifications

• Experience with one or more requirements, architecture, and/or MBSE software tools and experience in both structured (i.e. waterfall) and iterative (i.e. Agile) development methodologies
• INCOSE certified Systems Engineering Professional

Additional Preferences

• Experience with FDA class II or III medical device regulatory requirements with knowledge of drug product and medical device standards (i.e. cGMP, 21 CFR 820, ISO 13485, IEC 60601, ISO 11608, ISO 14971, IEC 62366, etc.)
• Familiarity with one or more requirements, architecture, and/or MBSE software tools and experience in both structured (i.e. waterfall) and iterative (i.e. Agile) development methodologies
• INCOSE certified Systems Engineering Professional
• Experience with medical devices as a platform
• Prior leadership or supervisory experience managing complex programs, systems engineering tasks, or multi-functional teams; works effectively across boundaries, effectively influences without authority, excels in a highly collaborative environment
• Previous organizational change management experience