Sr Reliability Engineer

Sr Reliability Engineer

Conduct and lead 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. Provide support to the new product development and risk management process, including FMEA and reliability testing.
• As a senior member of the Reliability Product Surveillance group, achieve team metrics requirements.
• Ensure timely, accurate and complete documentation of failure investigations of product complaints leading to root cause and corrective/preventive action.
• Perform trend analysis, identify trends, and determine/implement corrective action.
• Organize/lead cross functional teams to identify problem issues and drive product improvement process.
• Provide reliability engineering support to the new product development and risk management process; perform FMEAs 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 Product Surveillance Review Board presenting complaint trends and recommendations for corrective action and product improvement.
• Participate in and lead continuous improvement and process re-engineering projects in support of Stryker Orthopaedics' continuous improvement initiatives.
• Perform engineering and statistical analysis to access test results, determine trends, probability of failure, root cause and corrective action.
• Mentor and oversee the work of other Reliability Engineers and provide technical training and coaching to colleagues.
• Attend job-pertinent training classes.
• Perform these duties with little or no supervision and review and approve the work of less experienced colleagues.

Qualifications/Work Experience

QUALIFICATIONS:
-5 years experience leading failure investigations and/or performing failure analysis leading to root cause and corrective action.
-5 years experience performing FMEA analysis and reliability testing.
-5-10 years experience in a design and manufacturing environment.
-Applied knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation, and Medical Device Directive.
-Demonstrated expertise leading failure investigations and performing Root Cause Analysis, FMEA, and reliability testing.
-Demonstrated ability to manage complex or broad scope projects.
-Demonstrated verbal, written and interpersonal skills.
-Demonstrated ability to work in a team environment and to mentor less experienced engineers.
-Ability to work cross-functionally with Product Development, Operations, and business units; and to lead cross functional and divisional teams.
-Demonstrated problem solving and troubleshooting skills.
-Demonstrated ability to deliver positive, energetic support to a team, and to be an advocate for product excellence and quality.
-Demonstrated results orientation, multi-tasker, and quick learner; demonstrated ability to respond to the urgent needs of the team and track record of meeting agreed upon deadlines.
-Applied knowledge of Microsoft Office software including Excel, Word and Power Point.

Education and/or Special Training

EDUCATION:
Bachelor of Science Degree in Mechanical or BioMedical Engineering. Professional attainment of Certificate of Reliability or Quality Engineering (CRE or CQE) preferred.

Percent Travel Required