Sr. Software Validation Engineer
Operations Belen, Heredia
Join a team that is changing millions of lives.
Transforming smiles. Transforming lives. Transforming an industry.
At Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our teams are constantly pushing the boundaries of what’s possible.
Ready to join us?
About this opportunity
The Software Validation Engineer/Analyst role will work closely with the Software Validation Team, other quality and engineering personnel and various project teams throughout the organization and across multiple sites.
In this role, you will help provide regulatory guidance and perform validation duties to ensure all software validation projects and corresponding deliverables adhere to current regulations, industry standards,
In this role, you will…
Be responsible for supervision to junior software validation engineers. It includes:
- Evaluate and verify some issues discovered, log probable software defects in a defect tracking database.
- Review test data with all team members.
- Develop summary reports for entire tests performed and assign them as required.
- Ensure to archive all test methods and data in a suitable file archive system.
- Prepare validation plus acceptance criteria and evaluate test results to assure software attains requirements and parameters.
- Identify gaps, suggest solutions and lead enhancement to software validation procedures, processes, and practices.
- Ensure completeness and accuracy of software validation records. Head ownership and implement validation plan plus validation methodology.
- Ensure to the author and execute high level plus detail test parameters.
- Implement software validation engineering test plans, cases plus scripts.
- Implement validation activities, common system testing, acceptance testing, stress as well as stability testing.
- Report software validation test results in a structured way plus suggest deliverables quality internally or externally.
- Report about product quality to project management as required.
In this role, you’ll need …
- Professional degree in computer systems or related fields such as statistics, software engineering, etc..
- Experienced in software validation and testing, preferably on medical device software
- Bilingual English / Spanish
- Knowledge or certification Regulatory ISO 13485 and FDA is a plus.
- Certifications or experience in the software development life cycle.
- Good interpersonal skills and the ability to work cross-functionally.
- Able to understand how to plan, create, and execute tests that check if requirements meet performance, quality, and specific standards.
- Desire experienced working with interdisciplinary teams to create tests that measure performance and quality. This includes experience designing a list of standards and metrics and choosing the software, tools, and format for such tests.
- Knowledge about data analysis, statistics, quality assurance management, regulatory compliance, technical writing and/or fundamentals of manufacturing are pluses
Sound like a good fit?
Great! Click the Apply link below to let us know you are interested. Not the right fit? Don’t worry, there are lots of more opportunities. Please consider sharing this opportunity with others in your network.
Invisalign clear aligners, iTero Intraoral scanners, and OrthoCAD digital services that help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients.
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