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Systems Engineer: Design Architect
3 weeks ago
The Staff Systems Engineer plays a pivotal part in spearheading systems engineering efforts for both new product development and released products. This position is responsible for developing and maintaining system and product design architectures, ensuring that system-level requirements are properly documented and managed, and leading the definition of system interfaces.
Main Responsibilities:
- Ownership of Systems Engineering inputs and outputs for teams supporting either NPD or released product.
- Responsibility for 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 and supports the use of appropriate software tools for the creation and maintenance of the 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.
About You:
This role requires an 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 are essential. Additionally, you should be able to lead complex experiments independently, perform statistical analysis, interpret experimental results, and make sound conclusions. Effective problem-solving skills, self-direction, and strong interpersonal skills with the ability to collaborate in multi-disciplinary team settings are also required.