Senior Staff Engineer, Systems - San Diego

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:

Thesenior staff Systems Engineer works withthe development team by applying an interdisciplinary approach to the successful definition, development, integration, and testing of complex in vitro diagnostic systems.They will document user requirements, develop system requirements, participate in product architecture and design, drive risk analysis, and support integration and testing for new product introductions.

Key Accountabilities

Essential Functions:

• • Provide technical leadership to project teams.
  • Responsible for the development of the system requirements documentation and overall requirements management.
  • Applies architectural & design skills to work with senior development engineers to decompose the System Requirements into a structured hierarchy of sub-systems and interfaces. Creates system architecture documentation.
  • Participates in development activities, such as performing hazard and risk analysis, assisting with requirements and design, and attending design reviews, etc.
  • Works with product management and marketing to define user needs.
  • Drives system integration, optimization, and root cause analysis with the development team during system integration, Alpha testing, and device pre-Beta testing.
  • Uses statistical methods such as Design for Six Sigma (DfSS) and Design of Experiments (DoE) to increase product robustness and reliability.
  • Leads risk management activities (e.g., Design Risk Analysis) in accordance with ISO14971.
  • Ensures compliance with designcontrol regulations (21CFR820.30), ISO13485, and IVDR throughout the product lifecycle.
  • Works with the testing team to develop strategies for system level product integration and testing, including software, electrical, analytic, and mechanical aspects of the system.
  • Supports the clinical team as needed to ensure a structured approach to product validation.
  • Creates work breakdown structures as needed.
  • May create verification reports and overall verification summary.
  • Demonstrates excellent written and verbal communication skills.

Minimum Knowledge & Experience Required:

• BS/BA degree inCS,CE, EE, Biomedical or related engineering discipline required; MS/ME degree preferred.
• 10+ years industry experience.
• Experience in the full development lifecycle with at least one product required.
• Experience in Medical device development or other Regulated industry required.
• Experience with FDA ClassII orIII medical devices, including submission support (510(k) or PMA) preferred.
• Proven familiarity with ISO13485 quality management systems and design control best practices.

Skills & Capabilities:

• Experience applying DOE to systems under development.
• Experience in the application of Human Factors is desired.
• Experience leadingsystemverificationactivities.
• Experience in testing analog and digital/real-time embedded devices.
• Good communication and presentation skills.
• Good team player and leader.
• Comprehensive knowledge of 21CFRPart820 and ISO14971 risk management processes.
• Proficiency with requirements management tools (e.g., Jama, DOORS).

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 NAtalentacquisition@werfen.com 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 7,000 employees around the world comprise our Werfen team.

www.werfen.com