Engineer -inter

US-NJ-Mahwah
3 days ago
Job ID
2017-26801
Category
Engineering
Position Type
Contract (Full-Time)
# of Openings
3

Overview

Conduct/perform documented failure investigations on customer complaints leading to the identification of root cause and corrective/preventive actions. Ensure timely closure of complaints to comply with FDA requirements. Perform trend analysis and identify negative trends to target for improvement. Facilitate field actions as required. Provide support to new product development and risk management process, including FMEA and reliability testing.

Responsibilities

 

  • As a member of the Reliability Engineering group, achieve team metrics/requirements.
  • Ensure timely, accurate and complete failure investigations of product complaints leading to root cause and corrective/preventive action.
  • Perform trend analysis and identify trends.
  • Organize/lead a cross-functional team to help identify problem issue and drive product improvement process.
  • Provide support to the new product development and risk management process, performing FMEA and reliability testing.
  • Work with all product, manufacturing and quality teams to determine root cause and to ensure proper corrective actions have been identified, implemented and verified to be effective.
  • Participate in the Complaint Trend Review Board, presenting complaint trends and recommendations for corrective action and product improvement.
  • Participate in continuous improvement and process re-engineering projects as required in support of Client's Joint Replacement continuous improvement initiatives.
  • Perform engineering analysis to determine root cause and corrective action.
  • Attend job-pertinent training classes.

Qualifications

 

  • Bachelor’s Degree in Engineering or related field of study.
  • Prefer CQE certification and Six Sigma Green or Black Belt.
  • 3+ years of experience as a Reliability or Quality Engineer in a regulated design environment.
  • Prefer experience with medical device product development life cycle, including risk management and design/ process verification & validation
  • Knowledge of FDA QSRs, ISO 13485 Design Control Procedures and ISO 14971
  • Experience in conducting failure investigations, reliability testing, and/or performing failure analysis leading to Root Cause and Corrective Action
  • Demonstrated applied knowledge of Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, and Mistake Proofing/Poka Yoke.
  • Demonstrated ability to read and interpret CAD drawings
  • Demonstrated ability to advocate product excellence and quality
  • Demonstrated ability to effectively work cross functionally with other departments including Advanced Operations, Product Development, Regulatory and Marketing.
  • Demonstrated problem-solving and troubleshooting skills.
  • Demonstrated interpersonal and communication skills.
  • Demonstrated a positive, energetic approach to teamwork.
  • Demonstrated ability to learn quickly and multi-task
  • Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
  • Computer proficiency with Mini-tab or similar analysis program, Visio, MS Office.

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