Gail Musumeci
February 28th, 2007, 01:31 PM
SENIOR RELIABILITY ENGINEER POSITION
Medical Device Company
San Clemente, California
Cameron Health, Inc., a developmental stage medical device company, is creating the next generation of implantable electronic device utilizing state-of-the-art technologies. We are a team of specialized, high technology, creative individuals with decades of experience in solving difficult medical problems. Our current target is the development of a family of devices that will afford patient treatment that has been, until now, unattainable with the current therapeutic modalities and technologies.
We are currently looking for a qualified Reliability Engineer. A description of the position is attached. Once you review the job description and feel this is something you would be interested in pursuing, please send your resume to Gail Musumeci at careers@cameronhealth.com (careers@cameronhealth.com).
RELIABILITY ENGINEER
POSITION SUMMARY:
Support engineering to ensure high reliability product design and compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Class III Medical Devices.
DUTIES & RESPONSIBILITIES:
· Participate in writing and reviewing component, assembly, and system reliability requirement specifications.
· Participate in writing and reviewing design verification test (DVT) protocols, especially with regard to sample size, test power, and related statistics.
· Support and guide quality control activities, including: PFMEA, IQ/OQ/PQ, process capability, gauge R&R, and SPC.
· Implement internal quality system improvements, audits, and training.
· Perform design reliability analyses, including reliability mathematical models, allocations, and predictions.
· Perform and facilitate product risk analyses, including: Failure Modes, Effects, and Criticality Analysis (FMECA), Fault Tree Analysis (FTA), Risk Analysis, and HAZOP.
· Execute and facilitate CAPA implementation and management.
· Assist with performing root cause analysis of field returns, including data analysis (mining), identifying trends (systemic issues), and common cause issues for systems, peripherals, software, and components.
· Assist in planning and facilitating product design verification tests and component qualifications.
· Provide expertise and guidance in defining plans and executing reliability stress-strength analysis, accelerated testing methods, environmental stress screening, HALT, HAST, HASS, and Design of Experiments.
POSITION QUALIFICATION REQUIREMENTS:
· Bachelors degree in Engineering or related field. Masters degree preferred.
· ASQ Certified Reliability or Quality Engineer (preferred).
· Minimum four years experience in quality and/or reliability engineering (medical device experience preferred).
· Strong verbal and written communication skills required.
· Knowledge of reliability engineering and quality standards, handbooks, and specifications.
· Must possess sound knowledge of Microsoft Word, Microsoft Excel, along with various statistical programs (Minitab, SPSS).
· Expertise using reliability analysis software tools such as Minitab, SPSS, and Relex is preferred.
Medical Device Company
San Clemente, California
Cameron Health, Inc., a developmental stage medical device company, is creating the next generation of implantable electronic device utilizing state-of-the-art technologies. We are a team of specialized, high technology, creative individuals with decades of experience in solving difficult medical problems. Our current target is the development of a family of devices that will afford patient treatment that has been, until now, unattainable with the current therapeutic modalities and technologies.
We are currently looking for a qualified Reliability Engineer. A description of the position is attached. Once you review the job description and feel this is something you would be interested in pursuing, please send your resume to Gail Musumeci at careers@cameronhealth.com (careers@cameronhealth.com).
RELIABILITY ENGINEER
POSITION SUMMARY:
Support engineering to ensure high reliability product design and compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Class III Medical Devices.
DUTIES & RESPONSIBILITIES:
· Participate in writing and reviewing component, assembly, and system reliability requirement specifications.
· Participate in writing and reviewing design verification test (DVT) protocols, especially with regard to sample size, test power, and related statistics.
· Support and guide quality control activities, including: PFMEA, IQ/OQ/PQ, process capability, gauge R&R, and SPC.
· Implement internal quality system improvements, audits, and training.
· Perform design reliability analyses, including reliability mathematical models, allocations, and predictions.
· Perform and facilitate product risk analyses, including: Failure Modes, Effects, and Criticality Analysis (FMECA), Fault Tree Analysis (FTA), Risk Analysis, and HAZOP.
· Execute and facilitate CAPA implementation and management.
· Assist with performing root cause analysis of field returns, including data analysis (mining), identifying trends (systemic issues), and common cause issues for systems, peripherals, software, and components.
· Assist in planning and facilitating product design verification tests and component qualifications.
· Provide expertise and guidance in defining plans and executing reliability stress-strength analysis, accelerated testing methods, environmental stress screening, HALT, HAST, HASS, and Design of Experiments.
POSITION QUALIFICATION REQUIREMENTS:
· Bachelors degree in Engineering or related field. Masters degree preferred.
· ASQ Certified Reliability or Quality Engineer (preferred).
· Minimum four years experience in quality and/or reliability engineering (medical device experience preferred).
· Strong verbal and written communication skills required.
· Knowledge of reliability engineering and quality standards, handbooks, and specifications.
· Must possess sound knowledge of Microsoft Word, Microsoft Excel, along with various statistical programs (Minitab, SPSS).
· Expertise using reliability analysis software tools such as Minitab, SPSS, and Relex is preferred.