(Archived) Principal Systems Engineer (Medical Devices)

Reference Code: NEC01086

Principal Systems Engineer - Research and Development - Medical Device

Responsibilities: As a Principal Systems Engineer, you will use expert technical skills to conceive, plan, and lead R&D product development activities to achieve project goals. 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 Systems Engineer include:

• Applying technical expertise in mechanisms, fluidics and electronics to lead efforts in test method development, implementation and validation for medical device/systems
• Leading efforts in creating and developing fixtures and building test stations for characterization, experimenting and testing novel medical device/systems
• Assessing design feasibility and testing product functionality and/or confirm product capabilities
• Designing experiments using DOE methodology and analyze the test results using statistical tools
• Participating in the evaluation and assessment of competitive products, processes and/or new trends
• Engaging with the OEM’s to provide technical oversight and guidance on the evolution of the design
• Developing system modules to facilitate decisions concerning: system architecture, system requirements, design tolerance allocation and risk management
• Mentoring system engineers

Qualifications:

As a Principal 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 design transfer functions, system modeling and simulation, and risk management.

Additional requirements include:

• Bachelor's Degree in Engineering, required
• Advanced degree (Masters / PhD), strongly preferred
• 10 years minimum relevant experience as a product development engineer
• 10 years minimum medical device experience
• Instrument automation or scientific instrumentation, required
• Experience with ISO requirements and GMP guidelines, FDA regulations, design control and manufacturing scale-up process
• Design for Six Sigma, desired
• Six Sigma certification, desired

For consideration please forward updated resumes to [Register to View]