Mizuho OSI · 18 hours ago
Senior Systems Engineer- Medical Device
Union City, CA
Full-time
Onsite
Senior Level
$130K/yr - $150K/yr
5+ years expMizuho OSI is a leader in specialty surgery and patient positioning, focusing on improving patient outcomes in surgical procedures. The Systems Engineer will be responsible for medical device development projects, from technology exploration to integration with software-controlled systems, ensuring product quality and compliance with regulations.
BiotechnologyHealth CareManufacturing
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
Qualification
Required
Bachelor's Degree in Engineering and 5-8 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
Preferred
Familiarity with Engineering Applications like MatLab, LabView or EA
Benefits
Potential annual bonus
Comprehensive benefits package
Company
Mizuho OSI
Mizuho OSI is a medical devices company offering specialty surgical tables and reusable medical products.
201-500 employees
H1B Sponsorship
Mizuho OSI has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (8)
2023 (2)
2022 (8)
2021 (1)
2020 (4)
Funding
Current Stage
Growth StageRecent News
Company data provided by crunchbase