Senior Software Validation Quality Engineer
At Intuitive Surgical, we are seeking a highly skilled and experienced Senior Software Validation Quality Engineer to join our dynamic team. As a leader in the medical device industry, our company is dedicated to developing innovative technology that revolutionizes the way surgeries are performed. In this role, you will have the opportunity to utilize your expertise in software validation and quality assurance to ensure the safety, effectiveness, and reliability of our products. We are looking for someone who is passionate about quality, detail-oriented, and driven to make a positive impact in the healthcare field. If you have a strong background in software engineering, quality assurance, and a desire to be a part of a cutting-edge organization, we encourage you to apply for this exciting opportunity.
- Develop and implement software validation strategies and processes in compliance with industry standards and regulations.
- Lead and mentor a team of software validation engineers to ensure the timely and accurate completion of validation activities.
- Collaborate with cross-functional teams including software development, quality assurance, and regulatory affairs to ensure product quality and compliance.
- Define and maintain software validation protocols, test plans, and reports.
- Conduct risk assessments and identify potential hazards in software design and development.
- Perform software testing and document results to ensure that product requirements are met.
- Manage and maintain software validation documentation, including traceability matrices and change control records.
- Continuously improve and streamline software validation processes to increase efficiency and effectiveness.
- Participate in design and code reviews to ensure software quality and identify potential issues.
- Stay current with industry trends, regulations, and best practices related to software validation and quality assurance.
- Communicate validation status, risks, and recommendations to project teams and management.
- Collaborate with external suppliers and vendors to ensure their software products meet our quality standards.
- Identify and implement process improvements to enhance software quality and reduce validation cycle time.
- Participate in audits and inspections to ensure compliance with applicable regulations and standards.
- Act as a subject matter expert and provide guidance on software validation and quality assurance to project teams and stakeholders.
Extensive Experience In Software Validation: The Ideal Candidate Should Possess A Strong Background And Proven Experience In Software Validation, Including Developing And Executing Test Plans, Conducting Risk Assessments, And Documenting Results.
Knowledge Of Medical Device Regulations: Intuitive Surgical Operates In A Highly Regulated Industry, And The Senior Software Validation Quality Engineer Must Have A Thorough Understanding Of The Relevant Regulations And Standards, Such As Fda And Iso.
Strong Analytical And Problem-Solving Skills: As A Senior Software Validation Quality Engineer, The Ability To Analyze Complex Software Systems And Identify Potential Issues Is Crucial. The Candidate Should Also Be Able To Propose Effective Solutions To Address Any Identified Problems.
Excellent Communication And Collaboration Skills: This Role Requires Frequent Collaboration With Cross-Functional Teams, Including Software Developers, Quality Engineers, And Regulatory Experts. The Ideal Candidate Should Be Able To Effectively Communicate And Work With These Teams To Ensure Successful Software Validation.
Attention To Detail And Quality: Given The Critical Nature Of Intuitive Surgical's Products, The Senior Software Validation Quality Engineer Must Have A Keen Eye For Detail And A Strong Commitment To Quality. They Should Be Able To Identify Any Potential Risks Or Issues During The Validation Process And Ensure That All Necessary Steps Are Taken To Address Them.
Risk Management
Quality Assurance
Process Improvement
Test Automation
Agile Methodology
Root Cause Analysis
Validation protocols
Software testing
Verification and Validation
Test plan development
Compliance Standards
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Software Validation Quality Engineer in Sunnyvale, CA, USA is $120,000-$150,000 per year. This can vary depending on factors such as experience, education, and company size. Some companies may offer higher salaries and additional benefits such as bonuses and stock options.
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Intuitive Surgical Inc. is an American corporation that develops, manufactures and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery, most notably with the da Vinci Surgical System.
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