Werfen North America · 1 day ago
Principal Systems Engineer: Risk Management - Transfusion and Transplant
Norcross, GA
Full-time
Onsite
Lead/Staff
8+ years expWerfen North America is seeking a Principal Systems Engineer to lead the development and sustaining risk management activities for their Norcross products. The role involves working with cross-functional teams to develop and maintain risk management documents, and applying technical expertise in mechanisms, fluidics, and electronics for medical device development.
Health CareManufacturing
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
Qualification
Required
BS in Engineering required
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
Risk management expertise
Preferred
Advanced degree (MS/PhD) strongly preferred
Candidates having experience with developing System Hazard Analysis (SHA) files and Design Failure Mode Effect Analysis (dFMEA) files are preferred
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
Company
Werfen North America
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
Founded in 1959Bedford, Massachusetts, USA
1001-5000 employees
H1B Sponsorship
Werfen North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (12)
2023 (10)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Giovanni Russi
Chief Operating Officer
Dominique J.
Human Resources Business Partner
Recent News
2025-07-19
2025-05-17
2025-04-04
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