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Lead Quality Engineering activities for design, development, manufacturing and/or distribution of orthopedic implants and instruments to ensure a high level ...
For your reference, we have included the original job posting below.
Reliability Engineer
Job Number:
42019416
Company Name:
Stryker Corporation
Job Location:
Mahwah, NJ US
Job Category:
Engineering & Architecture
Reliability Engineer
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
As a member of the QA-Product Surveillance 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 Product Surveillance 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 as required to determine root cause and corrective action. Attend job-pertinent training classes as required.
Qualifications/Work Experience
QUALIFICATIONS:
3-5 years experience in a design and manufacturing environment, conducting failure investigations and/or performing failure analysis leading to root cause and correction action.
Experience performing FMEA analysis and reliability testing.
Applied knowledge of regulatory requirements: ISO 9001 or ISO 13485, Quality System Regulation and Medical Device Directive.
Demonstrated project management skills.
Demonstrated verbal, written and interpersonal communication skills.
Demonstrated ability to work in a team environment and to work cross-functionally with Product Development, Operations, and the Business Units.
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.
