Drive the future of medical device innovation as a Lead System Designer, focusing on cutting-edge systems engineering principles and processes. This role champions a holistic approach, integrating business and technical needs to deliver high-quality products that meet user demands. You'll be instrumental in the design, creation, and optimization of complex systems, from initial concept through to operational deployment.

This position offers autonomy within established frameworks, allowing for procedural modifications to ensure optimal outcomes in quality, volume, and timeliness. Your expertise will guide departmental execution and professional activities within a critical technical discipline, influencing the development of next-generation medical technologies.

Spearhead systems engineering for advanced medical devices, defining critical system requirements, architectures, and interfaces. You will manage end-to-end workflows across hardware, software, cloud, and connectivity.

Lead product definition and system design from ideation to commercialization, ensuring alignment with user needs, clinical workflows, regulatory mandates, and business goals. Own the comprehensive management and traceability of all requirements.

Conduct in-depth system architecture and design trade-off analyses, considering factors like performance, usability, cybersecurity, safety, reliability, scalability, serviceability, cost, and regulatory compliance. Drive risk management activities following ISO 14971, including hazard analysis, risk assessment, and mitigation verification.

Collaborate extensively with cross-functional teams including software, hardware, cloud, cybersecurity, quality, regulatory, clinical, manufacturing, and product management throughout the product lifecycle. Ensure adherence to medical device standards and regulations such as ISO 13485, IEC 62304, IEC 62366, IEC 60601 Series, and IEC 81001-5-1, alongside global regulatory requirements like FDA and MDR.

Lead integration efforts for imaging scanner subsystems, cloud platforms, networking, AI/analytics, and healthcare ecosystems. Champion cybersecurity and privacy-by-design principles for connected medical devices. Mentor engineering teams on best practices in systems engineering, design controls, risk management, and compliance.

A Bachelor's or Master's degree in a relevant engineering discipline such as Systems, Electrical, Computer, Software, or Biomedical Engineering is required.

Possess a minimum of 5 years of experience in systems engineering, product development, or technical leadership for complex products. Demonstrated experience developing regulated products under formal design controls and quality management processes is essential.

Exhibits a strong understanding of the medical device development lifecycle, encompassing requirements engineering, architecture, risk management, design verification, validation, and product release. Proven ability to work effectively with multidisciplinary engineering teams across hardware, software, systems, and cloud technologies.

Familiarity with global medical device standards and regulations, including ISO 13485, ISO 14971, IEC 62304, and IEC 62366, is crucial. Expertise in defining and managing system requirements, interfaces, and traceability throughout the development lifecycle is expected.