Senior Technical Systems Specialist

Job Overview:

The Staff Systems Engineer will play a pivotal role in spearheading systems engineering initiatives for both new product development (NPD) and released products.

This position is responsible for developing and maintaining system and product design architectures, ensuring system-level requirements are properly documented and managed, and leading the definition of system interfaces.

The ideal candidate will have extensive experience in electro/mechanical medical device product development, IVD device development, or lab automation development. A strong technical background and expertise 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 is also required.

The Staff Systems Engineer will be accountable for:

• 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.
• May lead system verification and validation activities for a multi-functional project team including protocol writing, execution and reporting.
• Contribute to the transition from R&D to manufacturing/service and supports resolving system issues for products in the field.
• Liaison between R&D and Quality/Reliability functions to inform/support functions based on quality procedures including risk analysis, verification/validation for specific subsystems.
• Critically assesses designs and test plans through robust Technical and/or Design Reviews.
• Facilitates broad perspectives, knowledge and experiences to promote the understanding and resolution of in-market and product development issues.
• Provide technical solutions to a wide range of difficult problems. Exercises latitude in determining technical objectives of the assignment methods and in selecting techniques and evaluation criteria for obtaining resolution using risk-based assessment (including dFMEA analysis and input into System Hazard Analysis).

Key Qualifications:

• Extensive experience in electro/mechanical medical device product development, IVD device development, or lab automation development.
• A strong technical background and expertise 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.
• Lead complex experiments independently, perform statistical analysis, interpret experimental results, and make sound conclusions.
• Apply creative problem-solving skills to novel or complex applications.
• 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.
• Collaborative leader committed to success of overall project; capable of encouraging others and leading without authority.
• Proven technical expertise and leadership in medium to large sized projects, with the ability to meet technical objectives and solve sophisticated challenges under conditions of ambiguity and rapid change.
• Strong problem-solving and debugging skills and an interest in learning new technologies.

Education & Training:

• BS/MS in relevant field such as biomedical engineering, electrical engineering, mechanical engineering, computer science, or related field.