Principal Systems Engineer: Risk Management - Transfusion and Transplant at Werfen GmbH

Norcross, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Jan, 26

Salary

0.0

Posted On

28 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Risk Management, Product Development, Medical Device, Test Method Development, Design for Six Sigma, Statistical Analysis, System Modelling, Fluidics, Electronics, Project Management, Design Control, GMP Guidelines, ISO Requirements, Mentoring, Data Analysis, Experiment Design

Industry

Medical Equipment Manufacturing

Description

Overview This person will be a key problem solver and a potential core team leader to plan and lead cross-funtional product development projects from concept to manufacturing. 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

Responsibilities

The Principal Systems Engineer will lead cross-functional product development projects from concept to manufacturing, utilizing expert technical skills. Responsibilities include planning R&D activities, assessing design feasibility, and mentoring system engineers.