Principal Software QA Eng

Job Summary

We are looking to add to our distinguished team to support our world class operating room tables, especially in the verification and validation of the software control.

Responsibilities

• Analyze, debug, and test embedded control system software and Windows-based application software.
• Write test documentation including protocols, risk assessment, software verification and validation, test suites, test results, and other analyses in accordance with FDA ISO software design control requirements.
• Interpret technical instructions, schematic drawings, component specifications, software code, and regulatory requirements.
• Diagnostic troubleshooting of circuits, boards, power supplies, and control systems using oscilloscopes, signal generators, and/or logic analyzers.
• Adhere to Mizuho OSI's software quality process. And if in a more senior role, create and/or maintain software quality processes.
• Collaborate with other engineers within the department and staff across the organization on Quality Assurance activities related to technical developments, and resolving software issues and test problems within standard regulations.
• Make sound and logical decisions, choose the appropriate courses of action based on the parameters of the situation at hand, and use continual improvement problem solving skills.
• 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: Plan, schedule, and coordinate internal and external software quality assurance resources.
• Train and instruct other members of the department and the company as appropriate, by passing along skills and information to assist them in their development and advancement either with one-on-one or with platform training skills.

Qualifications & Requirements

• For a Sr. level Bachelor's Degree in Computer Science or related field and 5-8 YOE, Master's Degree and 3+YOE, PhD Degree and 1+ YOE
• For a Principal level Bachelor's Degree in Computer Science or related field and 8-12 YOE, Master's Degree and 6+YOE, PhD Degree and 3+ YOE
• Knowledge in C and/or C# computer languages.
• Software test management experience in a Windows environment.
• Knowledge of software quality assurance principles, practices, and techniques.
• Ability to apply engineering principles using logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions.
• Medical devices industry experience preferred.
• Ability to clearly express oneself verbally and in writing in the English language.
• Ability to communicate effectively with employees and other business contacts in a courteous and professional manner.
• Ability to work effectively across multiple functions.
• Excellent computer skills including operating Windows based personal computers.
• Ability to efficiently and effectively use Microsoft products such as Outlook, Word, Excel, MS Project, and PowerPoint.
• Ability to function calmly in a fast paced environment managing multiple priorities simultaneously.
• Able to positively manage situations of a dynamic nature; to be able to modify plans, actions, and decisions in light of changing situations and circumstances while still meeting, or proposing modified, deadlines.
• Ability to demonstrate an understanding, and the regular use of a time management process, which systematically structures one's own work to provide for effective task performance and to plan and prioritize items to meet future demands.

Physical Requirements

The physical demands are representative of those needed to perform the essential functions of the job in an office environment. The duties of this job require the employee to stand and to use hands to manipulate very small objects and hand tools for long periods of time. The employee is required to stand, bend and stoop, walk and occasionally to lift up to 45 pounds during the normal course of work. Specific vision abilities required by this job include close vision. The employee may use equipment in an electrical laboratory environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.