Our client is a global Life Sciences organization looking for a DNG superuser.
* 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.