Systems Engineer II/III

Experteer Overview As a Systems Engineer II/III, you contribute to the development and launch of drug-device combination products within the Device and Combination Product Development - R&D team. You will lead multi-disciplinary integration to ensure patient-centric design and compliant performance. The role emphasizes DHF management, design controls, and risk-based decisions in a regulated environment. You collaborate across engineering teams, influence through a matrixed organization, and provide technical leadership to meet safety and regulatory requirements. This position offers impact at scale by shaping robust, compliant systems for innovative therapies. Compensation / Benefits * Manage DHF and design control documentation to regulatory standards * Lead cross-functional activities: needs definition, use case analysis, traceability, and requirements development * Define system/sub-system requirements and architect integrated solutions * Coordinate third-party development and ensure system integration * Conduct risk management planning, system risk assessment, use error risk assessments, and design validation * Provide technical leadership and ensure documentation meets safety and regulatory requirements * Facilitate communication across a matrixed organization and manage competing priorities * Contribute to broader application of systems engineering principles within the organization Tasks * Bachelor’s degree or higher with equivalent experience; Senior levels require 5-10 years (or 3-7 for Master; 1-4 for PhD per title) * Experience in product development within regulated industries (Medical Device, Pharma, Biotech) * Proven leadership and ability to influence internally and externally * Strong analytical, decision-making, and communication skills * Experience with design and development processes aligned to IEC 60601, ISO 14971, IEC 62304, 11608, 11040, ISO 13485, 21 CFR 820, MDR * Experience in user/stakeholder needs definition, requirements definition, risk management, and product architecture Key requirements *

aau_ system integration * Conduct risk management planning, system risk assessment, use error risk assessments, and design validation * Provide technical leadership and ensure documentation meets safety and regulatory requirements * Facilitate communication across a matrixed organization and manage competing priorities * Contribute to broader application of systems engineering principles within the organization Tasks * Bachelor’s degree or higher with equivalent experience; Senior levels require 5-10 years (or 3-7 for Master; 1-4 for PhD per title) * Experience in product development within regulated industries (Medical Device, Pharma, Biotech) * Proven leadership and ability to influence internally and externally * Strong analytical, decision-making, and communication skills * Experience with design and development processes aligned to IEC 60601, ISO 14971, IEC 62304, 11608, 11040, ISO 13485, 21 CFR 820, MDR * Experience in user/stakeholder needs definition, requirements definition, risk management, and product architecture Key requirements *