Medical Device Systems Engineer
Company: Mizuho OSI
Location: Union City
Posted on: June 6, 2021
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
- Exercise Intellectual discipline to analyze problems and
- Grit to drive challenging projects to completion in a fast-pace
- 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
- 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
- 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
- Perform engineering, integration, verification and validation
testing, including protocol development, report generation and
- 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
- Manage, prioritize and align work activities with project
- 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
Keywords: Mizuho OSI, Union City , Medical Device Systems Engineer, Other , Union City, California
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