Principal Systems Engineer: Risk Management

Job Information Number ICIMS-2025-9482 Job function R&D Job type Full-time Location T&T - Norcross - Norcross, Georgia United States Country United States Shift 1st About the Position Introduction 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. Overview The Principal Systems Engineer will lead the development and sustaining risk management activities for the Werfen Norcross products. They will work with the cross functional team to plan, develop, and maintain the risk management documents. Candidates having experience with developing System Hazard Analysis (SHA) files and Design Failure Mode Effect Analysis (dFMEA) files are preferred. Responsibilities Use expert technical skills, conceive, plan and lead R&D product development activities to achieve project goals. Leverage understanding of advanced engineering principles, advanced engineering methods, data and judgment to influence the course of product development activities. Apply technical expertise in mechanisms, fluidics and electronics to lead efforts in test method development, implementation and validation for medical device/systems. Lead efforts in creating and developing fixtures and building test stations for characterization, experimenting and testing novel medical device/systems. Responsible for assessing design feasibility and testing product functionality and/or confirm product capabilities. Design experiments using DOE methodology and analyze the test results using statistical tools. Interpret the results correctly and provide feedback effectively for design improvements. Participate in the design of new products and design improvements to existing products. Participate in the evaluation and assessment of competitive products, processes and/or new trends. Engage with the OEM's to provide technical oversight and guidance on the evolution of the design. Develop system modules to facilitate decisions concerning System architecture System requirements Design tolerance allocation Risk management Mentor system engineers Qualifications Education BS in Engineering required. Advanced degree (MS/PhD) strongly preferred Experience 8 years minimum relevant experience in product development/engineering (minimum 5 years of medical device experience) Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams Strong analytical and problem solving skills, as well as a good background in product development process Instrument automation or scientific instrumentation required Experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes Strong project management, prioritizing and multi-tasking skills to work within tight deadlines Design for Six Sigma (DFSS) experience highly desired Experience with requirements development from user needs Experience with system modelling and simulation Experience with design transfer functions Risk management expertise 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 Apply Now