Engineer - Degreed IV_SJM in Plano, TX at Volt

Date Posted: 9/18/2020

Job Snapshot

Job Description

Onsite EE Design and Compliance Engineering Lead (12-month contract)
Plano, TX

Volt has partnered with a growing manufacturing company in search of an Electrical Engineer!

Responsibilities:

  • Lead EU MDR and/or unplanned production issues (EOL, NCMR, Supplier Corrections)
  • Support design documentation preparation and review for market expansions
  • Run empirical and experimental analysis
  • Remediate Compliance Gaps
  • Lead product characterization and verification testing
  • Lead design updates for class II and class III medical products
  • Resolve and/or facilitate resolution of problems including identifying causes to prevent re-occurrence (CAPA)
  • Solve complex problems using hardware engineering knowledge and engineering best practices
  • Work cross functionally to determine the optimal course of action including impact to existing submissions and compliance certifications
  • Work with outside consultants, vendors, and the medical community
  • Ensure requirements of Design Controls are followed
  • Ensure that the quality system requirements are being met

Requirements:

  • Electrical Engineering Degree with 7 years of experience
  • Strong Experience with schematic and PCB layout design and simulation tools (Altium etc.)
  • Values and adheres to quality and design controls
  • Technical expert for compliance. Previous experience with of EU MDR and/or unplanned production issues (EOL, NCMR, Supplier Correction)
  • Proficiency demonstrated towards statistical techniques and design of experiments
    Experience with designing, testing medical devices and running empirical and experimental analysis
  • Understanding of PCB assembly processes
  • Relevant product sustainment or R&D experience in the medical device industry
  • Bachelor's degree in Electrical Engineering
  • Master’s degree in Engineering preferred
  • Demonstrated knowledge of risk management techniques
  • Demonstrated knowledge of CAPA process and root cause investigation
  • Experience working in a broader enterprise/cross division business unit model preferred

Volt is an Equal Opportunity Employer