Job Title
A highly skilled systems engineering professional to lead the development of new product lines and released products.
This role requires a strong technical background in electro/mechanical medical device product development, IVD device development, or lab automation development.
Key Responsibilities:
* Owning system engineering inputs and outputs for teams supporting NPD or released product.
* Developing and maintaining 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 and supporting the use of appropriate software tools for creation and maintenance of trace matrices.
* 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, including data analysis, interpretation, and communication of results and their impact through written reports, design reviews, and interactive discussions.
* Maintaining collaboration between R&D and Quality/Reliability functions to inform/support functions based on quality procedures including risk analysis, verification/validation for specific subsystems.
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.
* Ability to self-direct and manage own work while possessing strong interpersonal skills with the ability to collaborate in multi-disciplinary team settings, influence decision making, and build group consensus.
* Perform in a fast-paced, agile environment.