Software Test Engineer III

Bedford, MA, United States

Overview Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary:

Software Test Engineer III (Instrumentation Laboratory Company, a Werfen Company, Bedford Massachusetts): On behalf of a worldwide developer, manufacturer, and distributor of specialized diagnostic instruments for hemostasis, acute care, and autoimmunity products and services, will work as technical leader in the software quality assurance team within the R&D Software Engineering group for the GEM Premier blood gas analyzer product line. Will be responsible for developing, applying, and implementing software verification and validation methods, and practices to achieve product and systems quality goals.

Responsibilities Specific Responsibilities will include:

Complete assigned deliverables in accordance with approved schedules.

Plan, perform, and prioritize tasks that are moderately complex in nature in alignment with corporate goals.

Define and execute software verification and validation activities and report test results and defects to appropriate software development personnel.

Author documentation and participate in activities in support of design control.

Review and approve verification protocols, reports, and related commercial orders.

Identify product defects and recognize outliers in results. Explain and document product defects and their impact.

Effectively communicate complex technical information to a cross-functional team in the form of documentation, presentations, and/or technical summaries.

Review and approve Research & Development documents related to embedded software on new instruments.

Participate in software risk analysis activities.

Provide technical support for and/or lead investigations in support of development or on-market activities.

Provide input to and/or independently generate schedules for tasks related to assigned projects.

Provide technical guidance to other team members.

Recommend improvement initiatives to aid department practices.

This is a hybrid position working 3 days per week at the office in Bedford, MA and 2 days per week from a home office within commuting distance to Beford, MA. Position requires less than 5% domestic and international travel.

Qualifications Minimum Requirements:

Bachelor's degree in Information Technology, Computer Science, or a closely related technical field of study and 5 years of experience in an occupation testing software within the in vitro medical device or clinical sector.

Must also have: (I) Background (a) performing software test automation using Java or Python; (b) performing functional and non-functional tests; (c) tracking issues and managing defects; and (d) performing software validation and verification for testing in vitro medical devices; (II) Demonstrated expertise in manual test case authoring and reviewing; (III) Knowledge of (a) SCRUM Agile methodologies and their application in a highly regulated sector; (b) configuration management tools; (c) cybersecurity vulnerability scanning including approved tool setup and execution of the scans; and (d) external regulations for submissions for Software Contained in Medical Devices;(e) demonstrated ability to set up necessary test environment; (IV) Must have strong verbal and written communication skills.

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com

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