Job Description
We are seeking a highly skilled Systems Engineer to join our team. As a key member of our cross-disciplinary product development teams, you will contribute to the definition, design, and execution of Systems Engineering activities throughout all phases of the product lifecycle.
This role requires a strong technical background in electro/mechanical medical device product development, IVD device development, or lab automation development. You should have 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.
You will be 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.
In this role, you will ensure traceability from user needs to test evidence, support configuration management, and drive integration and defect tracking efforts.
Additionally, 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.
Key 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.
* Document 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 supports the use of appropriate software tools for the creation and maintenance of the 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.
Benefits:
A career at our company means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.
You will have the opportunity to help shape the trajectory of our products while leaving a legacy at the same time.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
We welcome people with the imagination and drive to help us reinvent the future of health.
About Us:
We prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are crucial in the fast-paced healthcare industry.
For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.
We are an Equal Opportunity/Affirmative Action Employer.