We are seeking a Principal Reliability Systems Engineer to join our team. The primary responsibility for this position is to implement fundamental reliability concepts in the design and development of our next generation IVD platforms, as well as provide support for continuing improvement projects on our legacy product portfolio. The ideal candidate is an experienced reliability engineer, seeking a product development opportunity where the primary responsibility will be to bring Design for Reliability (DFR) concepts, and engineering development expertise to our Systems Engineering team. If you’ve got the necessary qualifications for this position, we want to hear from you. Apply today!
This position is not eligible for sponsorship for work authorization by Wefen, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.
Principal Reliability Systems Engineer - Research and Development - Medical Device
Responsibilities
As a Principal Reliability Systems Engineer, you will use expert technical skills to conceive, plan, and lead R&D product development activities related to performance reliability. You will leverage understanding of advanced engineering principles, advanced engineering methods, data and judgment to influence the course of product development activities.
Responsibilities for Principal Reliability Systems Engineer include:
Applying technical expertise in mechanisms, fluidics and electronics to lead efforts in test method development, implementation and validation for medical device/systemsLeading efforts in creating and developing fixtures and building test stations for characterization, experimenting and testing novel medical device/systemsAssessing design feasibility and testing product functionality and/or confirm product capabilitiesDesigning experiments using DOE methodology and analyze the test results using statistical toolsEngaging with the OEM’s to provide technical oversight and guidance on the evolution of the design with a focus on performance reliabilityDeveloping system modules to facilitate decisions concerning: system architecture, system requirements, design tolerance allocation and risk managementMentoring system engineers
Principal Reliability Systems Engineer - Research and Development - Medical Device
QualificationsAs a Principal Reliaility Systems Engineer, you must demonstrate the ability to effectively and clearly communicate concepts, ideas and knowledge to other indiviuals and teams. Qualified candidates must have strong project management, prioritization and multi-tasking skills in order to work within tight deadlines. You must have a track record of career advancement and experience with reliability asessment and growth efforts.
Additional requirements include:
Bachelor's Degree in Engineering, requiredAdvanced degree (Masters / PhD), strongly preferred10 years minimum relevant experience as a product development engineer10 years minimum medical device experienceInstrument automation or scientific instrumentation, requiredExperience with ISO requirements and GMP guidelines, FDA regulations, design control and manufacturing scale-up processPrincipal Reliability Systems Engineer - Research and Development - Medical Device
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