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Principal Systems Engineering

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Location
MN
Job Type
Direct Hire
Date
Nov 16, 2018
Job ID
2630342
Our early stage medical device manufacturing start-up client is adding a Systems Engineering Director/VP to the team.  The hands-on manager will provide interdisciplinary research and product development leadership from inception through pilot production.  He or she must be able to work effectively with all functional groups to define system-level requirements and resolve cross-functional issues.

Your role with the company:
 
  • Define, plan, and execute development programs to implement design changes to the product that are necessary to support the clinical studies and to ensure consistent compatibility with the delivery device.  Key elements of these programs will be integrating new features based on user feedback and on-going product improvements.
  • Develop custom electronics for the delivery device, including systems to measure biological tissue capacitance to aid needle navigation, to track magnet movement, and to track the tip of the needle (i.e. GPS)
  • Clinical Study Technical Support: Technical support of product as part of any on-going clinical studies in the US and abroad, including overseeing the builds of field units, troubleshooting issues with field units, ensuring functionality and usability of field units, system readiness, and user requirements.
  • Lead cross-functional design and problem-solving activities.
  • Author product-level requirements and design documentation.
  • Lead product-level verification and validation activities.
  • Analyze design trade-offs necessary to meet the objectives of disparate functional groups such as marketing, clinical, regulatory, quality, R&D (electrical, mechanical, and software) and manufacturing operations.
  • Define strategic direction and direct other electrical engineers work responsibilities to meet timeline objectives.
 
 Desired Profile:
  • Bachelor's Degree in Electrical; Master’s Degree Preferred, or equivalent experience
  • 15+ years of progressively responsible system-level medical device design, development and validation experience throughout the entire product development cycle.
  • Strong technical design and leadership skills. Strong background in documenting requirements and providing traceability documentation.
  • Demonstrated experience in leading the design and development of embedded platform architecture for combination electro-mechanical systems.
  • Demonstrated experience in the development of testing procedures and equipment for verification and validation testing, and transfer into manufacturing and development of appropriate process manufacturing controls and documentation.
 
        Key Skills:
  • Cross-functional experience in multiple engineering fields such as electrical, software, and/or systems engineering.
  • Strong project management skills leading cross-functional teams, including task planning, system requirement definition, vendor selection, design & development, risk management, verification and validation, and transfer to manufacturing.
  • Experience with QA system controls and implementation and documentation throughout a system development life cycle to meet regulatory and quality requirements (e.g. FDA, ISO, IEC, etc…).