Experience in medical device verification and validation
5+ years in software development lifecycle
5+ years in Agile methodologies
3+ years as a software product owner or project manager
Experience with design controls in a regulated environment
Excellent communication and collaboration skills
Responsibilities
Identify and resolve complex test problems using advanced application knowledge
Handle quality assurance and test environment issues
Analyze software and perform ambiguity reviews of requirements
Collaborate with development teams to devise effective test strategies
Write detailed test plans, cases, and scripts
Execute test protocols and log defects
Review test documentation thoroughly
Benefits
Support for diversity and inclusion in the workplace
Local and global career growth opportunities
Clear career progression within a rapidly growing company
Flexible and casual work culture with employee events
Access to extensive training and mentorship programs
Bonuses through referral programs
Full Job Description
We are looking for a V&V Engineer(Validation Engineer for Medical Devices) to join our growing team in Santa Clara, CA!
Location: Santa Clara, CA (3 days onsite)
Position Overview The Software Test Engineer will be responsible for writing test procedures, test reports, executing test plans and filing bugs. The candidate must be comfortable working with sophisticated electro-mechanical systems, deploying new software releases and running the test protocols on the systems. The candidate will work in close relationship with the software team and other stakeholders to improve the test infrastructure, data collection, data analysis and measure software product quality and performance throughout the software development lifecycle. We are looking for a candidate that can work independently but also function well within a team and with other functional groups, is detailed, highly motivated and willing to take responsibility & ownership.
Responsibilities:
Uses advanced knowledge of applications and application testing in identifying, evaluating, and resolving highly complex test problems.
Responsible for handling highly complex quality assurance and test environment problems and issues.
Analyzes application specific software and performs ambiguity reviews of business requirements and technical functional specification documents.
Works with development teams to understand and review technical design to devise effective test strategy and is flexible enough to source out this information even without formal requirements
Writes detailed test plans/test protocols, test cases, test scripts and test scenarios
Executes test protocols, test cases, test scripts and scenarios and log/follow-up on defects.
Perform thorough review of test plans/test protocols, test cases, test scripts and test scenarios.
Works with other functional groups, and team members.
Required Skills & Experience:
Top Must Haves: 1. Manual/Functional experience - ~5+ years experience 2. Experience on medical device verification and validation
Ideal: Experience in surgical robotics
5+ years of experience working in all aspects of software development from concept and requirements through development, testing, traceability, release, and maintenance.
5+ years of experience in Agile methodologies.
3+ years of experience as a software product owner or technical program/project manager
Experience writing software requirements and user stories, and prioritizing stories based on customer and business needs.
Experience working with design controls in a regulated environment.
Experience working with competing priorities from multiple teams.
Experience with Jira and software branching.
Excellent communication, collaboration, and influencing skills.
Strong project and time management skills.
Preferred Skills & Experience: 1. Knowledge on Windows and Linux operating systems 2. Additional years of experience, experience with robotics systems 3. Software testing for sophisticated electro-mechanical systems (Medical device preferred). 4. Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.
Required Education:
Bachelor's in Software (or) Electrical/Electronics Engineering, or related field
Benefits:
Be a part of a company who strives to support for diversity and inclusion in the workplace - we are one, we are many at QualityAI. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences.
Local and global opportunities - we offer you internal rotation and international mobility opportunities to grow your career.
Clear view of your career and progression with the company - QualityAI is growing massively (since Jan 2021 - added more than 2000 engineers) and giving you the opportunity to grow with us.
Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers.
Never stop experimenting and learning with QualityAI Tech academy: 3000+ training courses, mentorship programs, technical tribes, sponsored certifications, leadership programs and much more.
Earn bonuses via our Client Referral and Employee Referral Program's. Refer and earn - tap your network for net-worth.
The salary range for the role is $90,000 - $100,000.
If you like what you have read, send us your resume and let's start talking!
