Our client is an International Medical Device organization that has over 70,000 employees worldwide. With over 100 years in the Healthcare Industry, our client has multiple product lines ranging from Class 1 to Class 3 medical devices. Our client specializes in data analytics, diagnostic technologies, clinical monitoring, and Imaging Systems.
• Assists with the “High Level” systems view of our product design (architecture and system requirements) and how it fits within a larger product portfolio, including ensuring proper allocation and ownership of requirements to the subsystem and component levels.
• Derives requirements from high-level marketing requirements into product-level functional requirements.
• Works hand in hand with the program manager, product manager, and cross-functional leads to ensure the overall product/solution system integrity from concept to end-of-life of the product, including meeting all expectations from major stakeholders like manufacturing, quality, regulatory bodies, and reliability in addition to customers and patients.
• Provides internal and external customer interface to arbitrate key architecture conflicts.
• Owns the safety risk management implementation and compliance.
• Coordinates with User Interface, Engineering, Marketing, Procurement, Operations, and V&V teams.
• Leads and participates in design reviews, including reviews of design inputs and outputs.
• Advises on change requests for system and related products.
• Provides technical leadership to ensure overall product development success.
• BS in relevant engineering field (MS degree preferred).
• Minimum of 8 years of experience in embedded hardware development, ideally in a regulated industry.
• Experience with the following standards is preferred, but not required: ISO 14971, IEC 60601-1, IEC 62304, IEC 60601-2-4, and/or IEC 60601-1-2.
• Has in-depth understanding of both hardware and software for integrated products.
• Strong understanding of safety risk management, including FMEA, design mitigations, and compliance to risk management standards.
• Working knowledge of tools and processes related to system configuration management from specifications development, traceability, version control, defect tracking, and field feedback.
• Experience distilling requirements from the system level into lower-level electrical and mechanical requirements.
• Understanding of digital signal processing and algorithm concepts.
• Experience in designing and assessing compliance to national/international standards.
• Experience with designing fault-tolerant systems.
• Proven ability to communicate in both verbal and written form to technical and non-technical customers, stakeholders, and various levels of management.