Senior Engineer

Job Overview:

The primary focus of this position is to spearhead systems engineering initiatives for both new product development and released products.

This role is pivotal in developing and maintaining system and product design architectures, ensuring that system-level requirements are accurately documented and managed.

• 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.
• Document system/product-level requirements and manage changes via team review, approval, and release process.
• Lead the definition and documentation of system interfaces and interface requirements.
• Ensure design traceability from user needs through requirements to test evidence and support the use of appropriate software tools for creating and maintaining trace matrices.
• Lead system/product-level integration, bug/defect tracking, and configuration management.
• Lead 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 support 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 assess designs and test plans through robust Technical and/or Design Reviews.
• Facilitate broad perspectives, knowledge, and experiences to promote understanding and resolution of in-market and product development issues.
• Provide technical solutions to a wide range of difficult problems. Exercising latitude in determining technical objectives of assignments methods and in selecting techniques and evaluation criteria for obtaining resolution using risk-based assessment (including dFMEA analysis and input into System Hazard Analysis).

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.
• 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.