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Director of Engineering

Summary

Looking for a dynamic engineering leader who can ensure all engineering projects, initiatives, and processes are in conformance with Neural Analytics’ established policies and objectives. This role reports directly to the VP of Engineering.  

Responsibilities

  • Responsible for hardware engineering areas that participate in the product delivery process: Planning, Product Development and V&V Testing
  • Works closely with VP of Engineering to ensure the organization as a whole is fully aligned with the vision and the strategy;
  • Pro-actively plan for and react to technical and resource challenges that occur within and among projects; ensure engineering teams are working efficiently; removing obstacles and barriers
  • Hands On leader who can deep dive into technical details when necessary
  • Ensuring the engineering team are planning for and delivering all product release efforts under FDA 21 CFR 820 and ISO 13485 Design Control processes.
  • Working knowledge of ISO 14971.
  • Identifying and resolving issues and conflicts within and involving Engineering
  • Developing, implement, report and manage key performance measures that indicate the health and trajectory of the engineering enterprise
  • Lead the engineering team in planning for and delivering all product release efforts.
  • Manages overall engineering costs and budget

Requirements

  • BS in EE or ME a must; MS or MBA strongly preferred
  • 12 years of directly related Engineering management; with 8 years in the medical device industry
  • Proven track record of launching products to market that have achieved 510k or PMA clearance from the FDA.
  • Project management experience such as: managing day-to-day operations, managing multiple teams, forecasting and achieving deadlines, etc.
  • Must be Hands On
  • Ability to drive the end-to-end product development lifecycle in an ISO 13485 environment
  • Strong analytical and problem solving skills
  • Strong written and verbal communication skills, interpersonal and presentation skills and the proven ability to influence and communicate effectively
  • Must be detail oriented and organized to ensure accuracy and quality of output 
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