Systems Engineer - Medical Device (Direct Hire)
Greater Dayton Area, OH
Job Requisition: 6947.1
Description for Systems Engineer - Medical Device:
The Systems Engineer (level II or III) will provide architecture definition to product development projects, develop system and solution requirements, identify and specify critical interfaces, and ensure end products are suitable to meet the needs of their users.
They will have a heavy ownership of planning and executing design verification and validation to verify design requirements are met. The ideal candidate would have some experience in software applications, embedded firmware, functional testing, system engineering, as well as some degree of hardware and software design experience.
Responsibilities for Systems Engineer- Medical Device:
- Work with Product Managers, customers and end-users to understand their needs, use-cases, operating environment and processes. Communicate the information with colleagues throughout the business.
- Work with Upstream Marketing and design teams to translate customer and business needs into solution and system requirements.
- Work with design teams to translate solution and system requirements and system risk analyses into subsystem and component-level requirements, designs and risk management approaches.
- Define, document, review, and communicate system-level requirements based on stakeholder and system architecture needs, ensuring the design of the device meets the need of customers throughout its life cycle.
- Actively participate on, and at times lead, cross-functional teams to develop new devices as well as address design issues or maintenance of existing products.
- Using a systems approach, lead cross-functional efforts to capture holistic definitions of medical device systems and interfaces and document them in architectural and system design documents.
- Lead the coordination of development high-level system interface specifications, including electrical, mechanical, and/or software interfaces.
- Create system-level verification and validation plans ensuring customer and regulatory requirements are satisfied.
- Ownership of verification/validation of a system including both HW and SW.
- Lead system-level safety and cybersecurity risk analysis activities as well as systems FMEAs
- Develop and qualify new system level test protocols, ensuring that test objectives are effectively incorporated.
- Partner with cross functional departments to derive testing scope, testing plans and deliver testing results for system level development and changes.
- Specify and acquire software to test, evaluate and stress the system.
- Work in a simulation environment for debugging system issues.
- Review results of executed test protocols, write summary reports and provide conclusions. Perform traceability analysis of test protocol to requirements.
- Create and update system documentation (specifications, design documentation, etc.) as required.
- Create system of automated test methods for devices and software.
- Integrate system test strategies and plans into NPD program plans.
- Provide guidance among engineers and co-ops
Secondary Responsibilities for Systems Engineer- Medical Device:
- Recommend selection, approval, and acquisition of hardware, software, networking components, and services.
- Testing and investigation of issues at customer sites when required.
- Knowledge of testing methods.
- Participate in design reviews.
Requirements for Systems Engineer- Medical Device:
- Ability to read bill of materials/BOM
- Ability to prepare Test Protocols and Test Reports.
- Ability to work independently and collaboratively.
- Strong analytical and communication skills (written and verbal).
- Ability to read engineering documents
- Ability to work under pressure and meet deadlines.
- Knowledge of FDA and ISO regulations.
- Ability to mentor and share knowledge.
- Lead by influence throughout the organization.
- Ability to understand customer and market needs.
- Strong planning and organizational skills.
- Strong mathematical and technical abilities.
- Ability to lead and manage projects and/or project teams.
- Proficient in the subject matter or the electronics areas of the assignments and influence the project team for the best practices related to that area.