Senior Systems Engineer

What you'll do

• Define user and stakeholder needs while performing use case analysis and traceability for drug/device combination products.
• Develop system and sub-system requirements to ensure robust, patient-centric product design and performance.
• Manage risk assessment processes including safety, usage errors, and regulatory compliance reporting.
• Lead the integration of third-party development activities and manage relationships with global engineering service firms.
• Oversee system architecture, decomposition, and interface management throughout the product development lifecycle.
• Ensure all systems design and documentation meet strict safety and regulatory standards like IEC 60601 and ISO 14971.
• Provide technical leadership and guidance to junior personnel while managing project schedules and risk mitigation plans.

What we're looking for

• Bachelor’s degree with 12 years experience, Master’s with 10 years, or PhD with 4 years of experience is required.
• Experience in full product development from initial concept to market release is required.
• Expertise in design and development processes conforming to IEC 60601, ISO 14971, IEC 62304, 11608, ISO 13485, 21 CFR 820, and MDR is required.
• Experience in user/stakeholder need definition, requirements definition, risk management, and product architecture is required.
• Proficiency with requirements management tools, V-model implementation, context diagrams, architecture diagrams, and interface management is required.
• Demonstrated technical leadership and the ability to provide guidance to less experienced personnel are required.
• Strong analytical, decision-making, and communication skills for writing regulatory materials are required.
• Experience in vendor communication, management, deliverable acceptance testing, and multi-cultural awareness (preferred).