Senior Systems Engineer- Medical Device

Mizuho OSI-posted 3 months ago
$130,000 - $150,000/Yr
Full-time • Mid Level
Fremont, CA
251-500 employees
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As Systems Engineer you will be part of a small, agile team; responsible for medical device development projects starting from technology exploration, product definition, to guiding integration with software controlled electromechanical systems; ending with product and release testing. We develop a broad spectrum of products from sterile disposables to complex capital equipment using a customer-centric, collaborative, innovation driven approach. We value ownership, calculated risk-taking, and tolerance for ambiguity as we build future devices and improve existing products. We are looking for you, if you have:  Curiosity to explore new approaches and innovative solutions. Intellectual discipline to analyze problems and synthesize solutions.  Grit to drive challenging projects to completion in a fast-pace environment. Enjoy working in a diverse, team driven environment.

  • Create innovative solutions to address user needs in products that differentiate the company in the market.
  • Translate customer needs into requirements and engineering specifications. Document design input & output.
  • Meld technical contributors into a unified team and collaborate to determine best technologies for the product.
  • Develop, manage and maintain design history files and related deliverables.
  • Develop, maintain and execute to plans, milestones, schedules and task lists.
  • Manage and logically organize 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.
  • Understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards). 
  • Share and provide technical expertise and guidance to other engineers and designers.
  • Lead projects and team as assigned.
  • Familiarity with Engineering Applications like MatLab, LabView or EA.
  • Bachelor's Degree in Engineering and 5-8 years of 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.
  • Ability to find creative or innovative solutions for design of products.  
  • Solid understanding of systems engineering principles and methods, system modeling and transformation applications.
  • Ability to make and communicate decisions in a timely fashion; to formulate and execute a course of action.
  • 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.
  • Adept use of Office Applications like MS Outlook, Excel, Word, PowerPoint, Visio and Project.
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