About Company Mizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outco…
Skills: Systems Engineering, Medical Device Development, Risk Management, Verification and Validation, Design History Files
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$82k–$150k/yr
Full-time
bachelor degree, postgraduate degree
Annual Bonus, Comprehensive Benefits Package
Posted 7d ago
~40 hrs/week
Responsibilities
Responsible for the full lifecycle of medical device development, from technology exploration and product definition to integration and release testing. This includes managing design history files, performing risk management, and supporting design transfer for manufacturability.
Requirements
Requires a Bachelor's degree in Engineering or a related field with varying years of experience based on the degree level (1-8 for Bachelor's). Candidates must possess strong analytical skills, proficiency in systems engineering principles, and excellent English communication skills.
Full job description
About Company
Mizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outcomes in spine and orthopedic surgeries along with disposable and reusable surgical patient care products.
Job Summary
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.
Responsibilities:
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).
At more senior levels you may:
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.
Qualifications & Requirements:
Bachelor's Degree in Engineering or related field 1-8 YOE, Master’s degree 1-3 YOE, PhD 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.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mizuho OSI is the leader in the markets for specialty surgery tables and patient positioning.
Industry
Medical Device
Company size
201-500 employees
Founded
1978
Headquarters
Union City, CA
LinkedIn followers
11,514
Mizuho OSI® is the market leader in specialized surgical patient positioning. Founded in 1978, it remains at the forefront of patient positioning solutions for the operating room, collaborating with top surgeons to develop technologies that are cornerstones in both hospitals and outpatient settings. The U.S based company's portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outcomes in spine and orthopedic surgeries and surgical pressure injury abatement products. Mizuho OSI is a wholly owned subsidiary of Mizuho Corporation located in Tokyo, Japan, a leading surgical equipment manufacturer.
Offices: 30031 Ahern Avenue, Union City, CA 94587, US
Specialty Surgical TablesPatient PositioningSpine Surgical TablesOrthopedic Surgical TablesDisposable and Reusable Surgical Patient Care Productsand Pressure Injury AbatementHealth CareBiotechnologyManufacturing
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