Sr. Design Assurance Engineer - Maple Grove

Teleflex Incorporated
Jul 17, 2019
Job Type
Full Time

Position Summary

  • Fulfill design assurance role on new product development (conception to launch) and sustaining projects
  • Lead planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.
  • Support Regulatory Affairs with creating submissions and responding to submission questions.
  • Primary responsibility is New Product Development; secondary responsibility is Sustaining Engineering.
  • Continued support and optimization of DA centric New Product Development deliverables and processes, accounting for cross functional system interactions.
  • Principal Responsibilities

  • Participate and lead New Product Development Phase Reviews and Design Reviews.
  • Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
  • Create and support the development and validation of new test methods.
  • Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA).
  • Develop the strategy and manage the execution of design verification and validation.
  • Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
  • Develop, execute, and manage First Article inspections.
  • Support regulatory approvals and responses to regulatory questions.
  • Support Sustaining Engineering for design and process changes to commercialized product.
  • Provide direction to design assurance engineering technicians supporting assigned projects.
  • Review and improve Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
  • Support the transfer of new product development projects from development to production.
  • Support internal and external audits.
  • Education / Experience Requirements

  • BA/BS in Engineering or physical sciences required.
  • Five years of related experience required.
  • Specialized Skills / Other Requirements

  • Ability to work independently and with minimal direction.
  • Ability to define, organize, and manage individual and team tasks.
  • Provide direction to extended and core team members.
  • Effective verbal and written communication.
  • Proficient in technical report writing and review.
  • Interpersonal skills; working in a team and as an individual contributor.
  • Structured and methodical problem-solving approach.
  • Strong understanding of design controls, risk management, statistics, test method validation, and new product development processes.
  • Strong understanding of industry regulations such as ISO13485 and FDA QSR's.