What are the responsibilities and job description for the Systems Test Engineer- Medical Device position at Mizuho OSI?
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 a Systems Test Engineer you will be part of a small, agile team responsible for medical device development projects from technology exploration, through integration with software - controlled electro-mechanical systems, and ending with product and release testing. The primary function of this position is to own all aspects of system integration and release testing, including ownership of the test approaches, design, development, and execution of test protocols, test report generation, as well as test unit configuration and issue management.
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.
Responsibilities :
- Perform engineering, regression, system, verification and validation testing.
- Take ownership of test protocols for release testing and Life / Reliability tests development, including protocol development, report generation and regression analysis.
- Develop clinically relevant test methods to ensure design requirements are sufficiently verified by collaborating with appropriate cross functional partners.
- Document processes, methods and tools for product testing and evaluation.
- Perform product evaluations and studies
- Support product sustaining activities including value engineering, reliability improvements, manufacturability improvements, and field issues with technical and impact analysis.
- Proactively engage with appropriate engineering teams on failure investigation and root cause analysis.
- Develop, manage, and maintain design history files and related deliverables.
- Develop, maintain, and execute 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 relating to the company’s products.
- Perform complaint, failure and risk management activities, develop mitigation and risk control strategies and generate supporting documentation.
- Support cross-functional Design Transfer process to ensure product designs are manufacturable & serviceable.
- Understand Mizuho OSI’s business objectives and the relationship between the Department and those objectives; to support and follow the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels set by Mizuho OSI, and to continually enable Mizuho OSI to be a great place to work.
- 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.
Qualifications & Requirements :
1 YOE
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Salary Range : $100,000 - $128,000 plus potential annual bonus and comprehensive benefits package
Salary : $100,000 - $128,000
