Systems Engineer
Union City, CA, US, 94587
Over 40 years of innovation and development, Mizuho OSI is a world-leading manufacturer of highly specialized surgical tables for spine and hip surgeries. 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. 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.
TOP REASONS TO JOIN THE MIZUHO OSI TEAM
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Privately held company with a tradition of market leadership and best-in-class innovation
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Fast-paced entrepreneurial culture focused on dramatically improving patient outcomes through personal empowerment
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Emphasis on continuous improvement and celebration of values of R.E.S.P.E.C.T. and the Mizuho way.
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Create innovative solutions designed and manufactured at our HQ in Northern California
As a 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:
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Curiosity to explore new approaches and innovative solutions.
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Intellectual discipline to analyze problems and synthesize solutions.
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Grit to drive challenging projects to completion in a fast-pace environment.
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Enjoy working in a diverse, team driven environment.
Here is what you will do day-to-day
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Create innovative solutions to address user needs in products that differentiate the company in the market.
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Translate customer needs into requirements and engineering specifications. Document design input & output.
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Meld technical contributors into a unified team and collaborate to determine best technologies for the product.
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Develop, manage and maintain design history files and related deliverables.
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Develop, maintain and execute to plans, milestones, schedules and task lists.
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Manage and logically organize data to identify and describe problems and assess the suitability and quality of technical solutions.
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Maintain up-to-date knowledge of medical devices, technologies and regulatory landscape relate to the
company’s products.
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Perform complaint, failure and risk management activities, develop mitigation and risk control strategies and generate supporting documentation.
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Perform engineering, integration, verification and validation testing, including protocol development, report generation and regression analysis.
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Develop and document processes, methods and tools for product testing and evaluation.
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Support cross-functional Design Transfer process to ensure product designs manufacturable & serviceable.
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Support product sustaining activities including value engineering, reliability improvements, manufacturability improvements, field issues with technical and impact analysis.
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Manage, prioritize and align work activities with project schedules.
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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).
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At more senior levels you may:
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Share and provide technical expertise and guidance to other engineers and designers.
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Lead projects and team as assigned.
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What you will need to be successful in this role:
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Experience and education – as outlined below, per job level.
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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.
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Ability to comprehend an extensive variety of technical instructions in mathematical and/or diagrammatic form and translate that into design requirement and/or performance.
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Ability to find creative or innovative solutions for design of products.
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Solid understanding of systems engineering principles and methods, system modeling and transformation applications.
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Ability to make and communicate decisions in a timely fashion; to formulate and execute a course of action.
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Ability to independently manage and prioritize work based on goals and objectives and provide deliverables in alignment with timelines and deadlines.
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Ability to adjust to changing timelines and priorities in a fast paced environment.
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Ability to collaborate cross-functionally and cross-organizationally and respond to the needs of internal customers.
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Strong interpersonal and communication skills and ability to effectively work in a team.
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Excellent written & verbal English communication skills and strong presentation skills.
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Adept use of Office Applications like MS Outlook, Excel, Word, PowerPoint, Visio and Project.
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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.
Salary Range: $80k - $171k DOE + potential annual bonus
Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland