Senior Reliability Engineer - Limerick in Limerick at Stryker Corporation

Date Posted: 10/25/2018

Job Snapshot

Job Description

Your key responsibilities:

  • 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.
  • 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 Stryker Orthopaedics' continuous improvement initiatives.
  • Perform engineering analysis to determine root cause and corrective action.
  • Attend job-pertinent training classes.

What are we looking for:

  • 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.

Work From Home: No

Travel Percentage: Up to 25%

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