Senior Systems Engineer

What you'll do

• Lead the definition of user and stakeholder needs, use case analysis, and system requirements.
• Manage system architecture, integration of third-party activities, and drug product development activities.
• Perform risk management planning, system risk assessments, and use error risk assessments.
• Ensure all systems design and documentation meet safety and regulatory compliance requirements.
• Manage relationships and deliverables with external engineering services firms and third-party development partners.
• Create and manage project schedules while identifying project risks and developing mitigation plans.
• Provide technical leadership and guidance to less experienced technical personnel.

What we're looking for

• Bachelor’s Degree with 12 years experience, Master’s with 10 years, or PhD with 4 years of experience.
• Thorough theoretical and practical understanding of your own scientific discipline.
• Experience through full product development from initial concept to market release.
• Expertise in design and development processes conforming to IEC 60601, ISO 14971, IEC 62304, 11608, ISO 13485, 21 CFR 820, and MDR.
• Experience in user and stakeholder need definition, requirements definition, risk management, and product architecture.
• Proficiency with requirements management tools, V-model implementation, context diagrams, architecture diagrams, and interface management.
• Demonstrated technical leadership and the ability to provide guidance to less experienced technical personnel.
• Experience in vendor communication, deliverable acceptance testing, and multi-cultural awareness (preferred).