Systems Engineer, Medical Device

About the role

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.

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 are manufacturable & serviceable.
• Support product sustaining activities including value engineering, reliability