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Your role:
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.
Keeps abreast of new developments in all relevant technological domains.
Advises on change requests for system and related products.
Provides technical leadership to ensure overall product development success.
You're the right fit if:
BS in relevant engineering field (MS degree preferred).
Minimum of 5 years of experience in embedded hardware development, ideally in a regulated industry.
Experience with the following standards is preferred, but not least: 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.
We’re looking for the candidate to have the following qualities:
Curious, smart, and creative
Good judgment and decision-making skills
Positive attitude
Takes Ownership
Excellent communicator and mentor
5+ years’ experience in a medical or other regulated industry (medical desired)
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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