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.

Position Summary:

The Senior Engineer, Systems Verification will work with the Development team in the system integration and testing of our In Vitro Diagnostic (IVD) products. The Senior Engineer, System Verification may provide leadership to a small team of other Verification Engineers, and typically works closely with other team members in the system integration and testing of our medical devices.

Key Accountabilities

• Develops verification planning documentation

• Creates and updates verification test protocols and test cases for system and subsystem requirements

• Creates test verification reports and other systems verification deliverables for systems verification activities

• Performs manual and automated test execution using electrical and mechanical test equipment and test fixtures as necessary.

• Assists in the production and maintenance of accurate product requirement to verification tracing documentation

• Develops automated test cases in support of functional and reliability testing with detailed documentation

• Documents product issues discovered during all product design and development phases as well as during formal verification activities using provided issue tracking tools

• Analyzes requirements and design specifications and provides feedback for potential conflicts and testability concerns

• Develops test strategies and test methods for system level product testing, including software, electrical, analytic, and/or mechanical aspects of the system.

• Assists with the development of project requirements

• Supports tracing of design inputs to design outputs

• Supports design activities and Participates in design reviews and code reviews

• Participates in hazard and risk analysis.

• Assists with system integration and debugging as needed.

• Assists in the investigation of customer feedback to help drive design changes with the possible interaction with clinicians, third-party vendors, manufacturers, and cross functional team members in marketing, sales, manufacturing and development

• Helps in determining required verification resources and work schedule estimates for project or individual product design changes

• Mentors others to develop skills necessary to perform job functions related to systems verification

• Leads the effort to breakdown, organize and help manage verification activities

• May lead scrum meetings for daily verification activities related to a project or verification team deliverable.

• May present verification plans for a project

• Works well in a team. May participate in interviews for new department personnel as necessary.

• May work on process improvement activities.
• Other duties as assigned with or without accommodation.

Networking/Key relationships

Research and Development, Quality Engineering, Product Management.

Minimum Knowledge & Experience required for the position

• BS/BA degree in CS, EE, ME, Biomedical or related Engineering discipline required.
• Minimum of seven (7) years of previous experience required; medical device industry experience preferred.
• Experience in the full development lifecycle for product delivery to market of at least one product required.

Skills & Capabilities:

• Test automation experience and familiarity with scripting languages such as Gherkin and Python desired.
• Testing experience in medical device development or other Regulated industry is preferred.
• Ability to articulate the need for electro-mechanical test equipment and/or test fixtures
• Experience in developing and writing of system/subsystem requirements for product development is desired.
• Understanding of multiple disciplines from electrical, mechanical, and software is desired.
• Familiarity with requirement management, test management, documentation release management and issue tracking tools
• Familiarity with software development lifecycle as described by IEC 62304
• Must demonstrate good document practices (GDP).
• Familiarity with using Agile methodology for product verification activities.
• Good communication and presentation skills.
• Strong planning and organizational skills required.

Travel requirements:

Less than 5% of the time

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 NAtalentacquisition@werfen.com for assistance.

www.werfen.com