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Systems Engineer, Medical Device 

EOE StatementMizuho OSI is an Equal Opportunity Employer and makes business decisions based on job related criteria only. Company policy prohibits unlawful discrimination based on race, color, religious creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, sexual identity, or any other consideration made unlawful by federal, state or local laws.
Category R&D Engineering  
Location Mizuho OSI Corporate Office - Union City, CA  

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).
Position Requirements

What you will need to be successful in this role:

  • Bachelor & 2-5 years of experience. Master & < 1 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.
  • Familiarity with Engineering Applications like MatLab, LabView or EA.

What you need to be prepared for:
The physical demands are representative of those needed to perform the essential functions of the job in an office environment. Walking or standing within the office areas and/or Lab is also required for testing, operation of office equipment, and for attending meetings.

During product testing, the employee may be required to climb or balance and stoop, kneel, crouch, or crawl.? Walking or standing is routinely required; bending, kneeling and stretching may be required for the testing or operation of capital equipment.?

The employee must regularly lift and/or move up to 50 pounds, and frequently push or move up to 150 pounds.? Specific vision abilities required by this job include close and far vision, color vision.

Some work activities may also be performed on the production floor.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

NOTE: This job description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Employees will be required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.

At Mizuho OSI, we believe better solutions and decisions are born of diversity and are proudly an EEO/AA employer. We offer a comprehensive benefits package that includes: medical, dental, vision, life insurance, 401k with matching, educational assistance and more.

Mizuho OSI values the service Veterans and their family members have given to our country and we support the hiring of returning Service Members and military spouses. If you are a Veteran or wounded warrior and would like assistance with the employment process at Mizuho OSI, please contact HR at (510) 429-1500.

If you are a person with a disability or a disabled Veteran and are applying for a job with Mizuho OSI, we would like to ensure your application process goes as smoothly as possible. If you need additional assistance, information or answers to your questions, feel free to contact HR at (510) 429-1500.

Open Date 5/19/2021  
Full-Time/Part-Time Full-Time  
About the Organization Top Reason To Join The Mizuho OSI Team
• Privately held company with a tradition of market leadership and best-in-class innovation
• Fast-paced entrepreneurial culture focused on dramatically improving patient outcomes through personal empowerment
• Emphasis on continuous improvement and celebration of our values of R.E.S.P.E.C.T. and the Mizuho OSI Way.
• Create innovative solutions designed and manufactured at our HQ in Northern California

The Mizuho OSI Way
In 1978, we set out to change the way patients undergo surgery. As a Mizuho OSI customer, you can expect our commitment to the following…
• We commit to your satisfaction. If you are dissatisfied, we will strive to make it right.
• We do things the right way. We commit to hire people with competence, generosity and a caring attitude.
• We motivate our employees to use their individual strengths to provide creative solutions, changes, and innovations.
• We anticipate your needs through customer experiences, thus nurturing our relationships.

Collectively, this creates an environment that enables and inspires healthcare professionals to improve the lives of patients.
Dare to go further. Care to do more.

This position is currently accepting applications.

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