Job Opportunity:
We are seeking a Staff R&D Engineer to lead systems engineering efforts for both new product development and released products.
* Ownership of Systems Engineering inputs and outputs for teams supporting either NPD or released product.
* Development and maintenance of system/product design architecture and system/product requirements.
* Documenting system/product-level requirements and managing changes via team review, approval, and release process.
* Leading the definition and documentation of system interfaces and interface requirements.
* Ensuring design traceability from user needs through requirements to test evidence.
* Leading system/product-level integration, bug/defect tracking and configuration management.
* Leading the system evaluation process through development and execution of system level test plans and protocols.
* May lead system verification and validation activities for a multi-functional project team.
* Liaison between R&D and Quality/Reliability functions to inform/support functions based on quality procedures.
* Critically assessing designs and test plans through robust Technical and/or Design Reviews.
* Providing technical solutions to a wide range of difficult problems.
Requirements:
* Extensive background in electro/mechanical medical device product development, IVD device development, or lab automation development.
* A strong technical background and experience within Systems Engineering – Requirements Management, Hazards Analysis, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Reliability Engineering, and Failure Modes Effects Analysis.
About Us:
We develop advanced, connected medical technologies that support medication delivery, diagnostics, and infection prevention. Our team plays a key role in designing smart infusion systems, molecular diagnostic platforms, and digital health solutions that improve patient safety and hospital efficiency.
Your Role: As a Staff R&D Engineer, you will be responsible for leading systems engineering efforts for our new product development and released products. You will work closely with our R&D and Quality/Reliability functions to ensure that our products meet the highest standards of quality and reliability.