Principal Software QA Eng

Mizuhosi; Union City, Northern (CA, KY); Hybrid; USD 126,000 - 158,000; Full time

Benefits offered by this job

Comprehensive benefits package

Annual bonus

Job summary

Mizuho OSI is seeking a senior QA/test engineer to verify and validate software controlling medical devices, including embedded systems and Windows applications. The role emphasizes quality analysis, documentation, and collaboration with engineers to meet regulatory standards.

The ideal candidate has strong communication, problem solving, and teamwork skills, with knowledge of C/C# and familiarity with Microsoft tools, and aims to uphold rigorous software quality processes.

Qualifications

• Bachelor's degree in Computer Science or related field required for Sr level; years of experience vary by degree level.
• Master’s Degree adds seniority; PhD adds more seniority and years of experience.
• Knowledge of C and/or C# languages and software QA principles is required.

Responsibilities

• Analyze, debug, and test embedded control system software and Windows-based applications.
• Write test documentation including protocols, risk assessments, and test results to meet FDA ISO design control requirements.
• Interpret technical drawings, specifications and regulatory requirements.
• Troubleshoot circuits, boards, power supplies, and control systems with diagnostic tools.
• Adhere to software quality processes and help improve them for senior roles.
• Collaborate with other engineers on QA activities and test problem resolution.

Skills

C

C#

Test management

Windows

Embedded software

Education

Bachelor's Degree in Computer Science or related field

Master’s Degree in Computer Science or related field

PhD in Computer Science

Tools

Microsoft Project

Microsoft Word

Microsoft Excel

Outlook

PowerPoint

Job description

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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

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. The Ideal Candidate will bring the following qualities:

• A passion for software quality through analysis, testing, and assembling object evidence.
• An exceptional team member naturally collaborates with other engineers to achieve goals.
• Strong written and verbal communication skills.

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.

What you need to be prepared for:

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.

Salary range: $126,000 - $158,000 DOE + annual potential bonus + comprehensive benefits package

EOE STATEMENT

Mizuho OSI is an Equal Opportunity Employer and makes business decisions based on job related criteria only. Company policy prohibits unlawful discrimination based on race, color, religious creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, sexual identity, or any other consideration made unlawful by federal, state or local laws.

Mizuho OSI conducts criminal conviction background checks and drug screening through a third-party screening vendor which includes searches of address history, criminalconvictions,court records,education verification, employment verification and reference checks. In addition, depending on the nature of the position for which you are applying, a motor vehicle driving report, a credit report, and/or ID checks in other non-U.S. countries are also included.

Criminal conviction background checks will run after an applicant has received and accepted a conditional offer of employment. After a conditional offer is made and before any background check is performed, applicants will receive background check disclosure and consent forms under state and federal laws, such as the Fair Credit Reporting Act and the Investigative Consumer Reporting Agencies Act. Existence of a criminal record is not an automatic bar to employment. An assessment will be made about whether the conviction has a direct and adverse relationship to the job in question.No job offer will be withdrawn, and no adverse action will be taken against any employee, based on the results of a criminal conviction background check, without an individualized assessment of whether the applicant’s conviction history has direct and adverse relationship with the specific duties of the job in question.

Top Reasons To Join The Mizuho OSI Team

• Privately held company with a tradition of market leadership and best-in-class innovation
• Fast-paced entrepreneurial culture focused on dramatically improving patient outcomes through personal empowerment
• Emphasis on continuous improvement and celebration of our values of R.E.S.P.E.C.T. and the Mizuho OSI Way.
• Create innovative solutions designed and manufactured at our HQ in Northern California

The Mizuho OSI Way

In 1978, we set out to change the way patients undergo surgery. As a Mizuho OSI customer, you can expect our commitment to the following…

• We commit to your satisfaction. If you are dissatisfied, we will strive to make it right.
• We do things the right way. We commit to hire people with competence, generosity and a caring attitude.
• We motivate our employees to use their individual strengths to provide creative solutions, changes, and innovations.
• We anticipate your needs through customer experiences, thus nurturing our relationships.

Collectively, this creates an environment that enables and inspires healthcare professionals to improve the lives of patients.

Dare to go further. Care to do more.

BENEFITS

At Mizuho OSI, we believe better solutions and decisions are born of diversity and are proudly an EEO/AA employer. We offer a comprehensive benefits package that includes: medical, dental, vision, life insurance, 401k with matching, educational assistance and more.

FOR OUR SERVICE MEMBERS AND VETERANS

Mizuho OSI values the service Veterans and their family members have given to our country and we support the hiring of returning Service Members and military spouses. If you are a Veteran or wounded warrior and would like assistance with the employment process at Mizuho OSI, please contact HR at [phone].

FOR PERSONS WITH DISABILITIES

If you are a person with a disability or a disabled Veteran and are applying for a job with Mizuho OSI, we would like to ensure your application process goes as smoothly as possible. If you need additional assistance, information or answers to your questions, feel free to contact HR at [phone].