System Engineer

We are seeking a skilled Systems Engineer to design, implement, and maintain complex systems that support business operations and technical infrastructure. This role is responsible for ensuring system reliability, scalability, and performance while collaborating with cross-functional teams to deliver efficient and secure solutions., Manage and own all aspects of system requirements and validation planning for new product development.

• Drive requirements discussions to turn User Requirements into testable Product Requirements.
• Manage Usability Engineering deliverable, including planning, execution, and reporting of usability evaluations.
• Understand impact of detailed design on the overall system to create detailed test strategies.
• Collaborate with test engineers to author verification plans, protocols, test cases, summary reports, trace matrix and other related technical documentation.
• Work with project managers and hardware/software engineers for execution for key programs and releases.
• Work with quality engineers to drive risk management initiatives in support of Design Controls.
• Interface with Regulatory Affairs and support regulatory assessments and documentation, including Pre-Sub
• Support review and generation of technical documentation including IFU, technique guide, user manual, etc.
• Consult on training material development, field team training, and product launches * Participate in post-market surveillance and customer support activities throughout the product life-cycle.

• Writing and managing system requirements for a Medical Device
• Authoring verification and validation test plans and protocols and executing tests * Authoring and/or participating in design reviews, design FMEAs, and documentation for regulatory submissions (such as for FDA, EU MDR)
• Performing user needs -> requirements -> design outputs -> validation/verification trace activities
• Designing/managing usability studies

At OpenArc, we prioritize your career success and strive to build exceptional technical teams for our clients. By understanding your experience and aspirations, we ensure to present you with rewarding and fulfilling opportunities.

As an employee of OpenArc and our clients, you will be eligible to participate in a comprehensive benefits package.

OpenArc - Empowering Your Career. As a leading IT staffing firm, we are dedicated to connecting talented professionals with your ideal opportunities. We are currently seeking a qualified Systems Engineer to join our client's organization and contribute to their ongoing success.