Job Description
As a Senior Systems Engineer, you will play a critical role in leading cross-disciplinary product development teams and defining, designing, and executing systems engineering activities throughout all phases of the product lifecycle.
You will contribute to the development of electro-mechanical medical device products, IVD devices, lab automation development, or regulated environments such as automotive or aerospace.
This position involves 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 engineer is responsible for traceability from user needs to test evidence, supports configuration management, and drives integration and defect tracking efforts.
You will oversee system evaluation processes, including test planning, execution, and data analysis, while facilitating collaboration between R&D, Quality, and Reliability teams to resolve technical challenges.
Main Responsibilities:
* Ownership of systems engineering inputs and outputs for teams supporting new product development or released products.
* Responsibility for developing and maintaining system/product design architecture and system/product requirements.
* Documentation of system/product-level requirements and managing 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 creation and maintenance of 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.
Required Skills and Qualifications
An extensive background in electro-mechanical medical device product development, IVD device development, lab automation development, or a regulated environment such as automotive or aerospace.
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.