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Medical Device Systems Engineer

Company: Mizuho OSI
Location: Union City
Posted on: June 6, 2021

Job Description:


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 electro-mechanical 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 the ability to:

  • Be curious to explore new approaches and innovative solutions.
  • Exercise 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.

Here is what you will do day-to-day

  • 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.
  • Share and provide technical expertise and guidance to other engineers and designers.
  • More senior level engineer may lead projects and team as assigned.
  • 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).

Keywords: Mizuho OSI, Union City , Medical Device Systems Engineer, Other , Union City, California

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