Systems Engineer R&D
Union City, CA 94587 US
- Bachelor's Degree in Engineering (Mechanical/Electrical/Industrial/Computer Sci) along with 4 yrs of experience
- MatLab, LabView, Jama or EA. Office Applications like MS Outlook, Excel, Word, PowerPoint, Visio and Project.
- Medical Device development experience
- Strong analytical skills and ability to apply engineering principles using logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to comprehend an extensive variety of technical instructions in mathematical and/or diagrammatic form and translate that into design requirement and/or performance.
- Experience with at least one full product development cycle
- Solid understanding of systems engineering principles and methods, system modeling and transformation applications.
- Product testing or V&V experience, documentation
- Ability to independently manage and prioritize work based on goals and objectives and provide deliverables in alignment with timelines and deadlines.
- Ability to adjust to changing timelines and priorities in a fast paced environment.
- Ability to collaborate cross-functionally and cross-organizationally and respond to the needs of internal customers.
- Strong interpersonal and communication skills and ability to effectively work in a team.
- Excellent written & verbal English communication skills and strong presentation skills.
- Translate customer needs into requirements and engineering specifications.
- Develop, manage and maintain design history files and related deliverables.
- Develop, maintain and execute to plans, milestones, schedules and task lists.
- Manage data to identify and describe problems and assess the suitability and quality of technical solutions.
- Maintain up-to-date knowledge of medical devices, technologies and regulatory landscape relate to the company’s products.
- Perform complaint, failure, and risk management activities, develop mitigation and risk control strategies and generate supporting documentation.
- Perform engineering, integration, verification, and validation testing, including protocol development, report generation and regression analysis.
- Develop and document processes, methods and tools for product testing and evaluation.
- Support cross-functional Design Transfer process to ensure product designs manufacturable & serviceable.
- Support product sustaining activities including value engineering, reliability improvements, manufacturability improvements, field issues with technical and impact analysis.
- Manage, prioritize and align work activities with project schedules.