Full Time: Systems Engineering Senior

Full-time
Shift
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. 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.
The Senior Systems Engineer supports system integration, verification, validation, defect analysis, and remediation activities throughout product development. This role is responsible for translating user needs and system requirements into system-level verification and validation test cases, executing and documenting testing activities, supporting product risk management, and ensuring compliance with applicable regulatory requirements and standards. The engineer collaborates with cross-functional teams to analyze test results, identify issues and risks, support issue resolution, and verify the implementation and effectiveness of risk controls.
This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.
Owns system-level defect analysis and remediation during System Integration, Verification, and Validation phases.
Supports Product Risk Management activities, regulatory and standards compliance, and country approval efforts.
Conducts risk analyses, including Design Failure Mode and Effects Analysis (DFMEA), and supports the development of risk control measures.
Executes and documents system integration, verification, and validation testing involving hardware, software, subsystems, and external interfaces.
Analyzes test results, identifies issues and risks, and collaborates with cross-functional teams to support timely resolution.
Supports Product Safety Risk Management activities by verifying implementation and effectiveness of assigned risk controls in a regulation-compliant manner.
Conducts cascade analysis and error budget allocation
Independently generates predictable schedules for activities related to assigned projects.
Knowledge of medical device standards and regulations, including ISO 14971, IEC 62304, IEC 62366, and FDA GMP/QSR, and their impact on verification and validation activities.
Ability to analyze test results and identify issues and risks.
Ability to support risk management activities, including DFMEA and risk control verification.
Experience with requirements management, digital traceability tools, and test automation preferred.
Knowledge of system integration principles and system-level testing methodologies.
Understanding of embedded software design, implementation, integration, and test activities.
Ability to diagnose and troubleshoot system performance issues using equipment, schematics, and algorithm analysis.
Programming experience, preferably Python.
Experience using test and measurement equipment, including oscilloscopes, digital multimeters (DMMs), and logic analyzers.

Bachelor's degree in Engineering, Science or a related field

Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
In vitro medical device experience highly desired.
Language: Proficiency in English language required

International Mobility:

~ Travel R equirements:

~ Some domestic and international travel may be required.

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 View email address on click.appcast.io.