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Werfen is a growing, family-owned, innovative company founded in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our OEM business line, we research, develop, and manufacture customized assays and biomaterials. We operate in 30 countries directly, and in more territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, with a workforce of over 7,000 employees.
Our success stems from our focus on rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We are passionate about providing healthcare professionals with comprehensive solutions to improve hospital efficiency and patient care.
Job Summary:
Software Test Engineer III at Instrumentation Laboratory (a Werfen Company, Bedford, MA): As a technical leader within the R&D Software Engineering group, you will work on the GEM Premier blood gas analyzer product line. Your role involves developing and implementing software verification and validation methods to ensure product and system quality.
Responsibilities
Key responsibilities include:
* Completing assigned deliverables on schedule.
* Planning, performing, and prioritizing moderately complex tasks aligned with company goals.
* Defining and executing software verification and validation activities, reporting results and defects.
* Authoring documentation and supporting design control activities.
* Reviewing and approving verification protocols and reports.
* Identifying product defects, analyzing outliers, and documenting impacts.
* Communicating technical information effectively through documentation and presentations.
* Reviewing R&D documents related to embedded software on new instruments.
* Participating in software risk analysis.
* Providing technical support and leading investigations.
* Generating project schedules and providing technical guidance.
* Suggesting process improvements.
This is a hybrid role with 3 days in Bedford, MA, and 2 days remote. Less than 5% travel is expected.
Qualifications
Requires a Bachelor’s degree in IT, Computer Science, or related field, with 5+ years in software testing within the in vitro medical device or clinical sector. Must have experience with:
* Test automation using Java or Python.
* Functional and non-functional testing.
* Issue tracking and defect management.
* Software validation and verification for in vitro medical devices.
* Manual test case creation and review.
* SCRUM Agile methodologies, configuration management tools, cybersecurity scanning, and regulatory submissions for medical device software.
* Ability to set up test environments and strong communication skills.
If you are eager to learn and face daily challenges, we encourage you to apply with your resume or CV.
Werfen is an Equal Opportunity Employer committed to diversity. We prohibit discrimination and harassment based on race, gender, religion, or other protected characteristics. For accommodations during the application process, please contact us.
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