What are the responsibilities and job description for the Principal Systems Engineer: Risk Management - Transfusion and Transplant position at Werfen?
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
