Sr. Quality Engineer - Hardware Job in Lowell, MA 01850
Title :
Sr. Quality Engineer - Hardware
Company :
C. R. Bard
Location :
Lowell, MA 01850
Date Acquired :
12/19/2009 12:57:20 AM
Sr. Quality Engineer - Hardware
/Category:, Job ID:, Standard Title:, Career Level:, Location/Division:, Relocation:, Posted Date:, Close Date:">
Industry Title
/Category: Medical Device / Quality
Job ID: 2009-4024
Standard Title: Sr. Quality Engineer - Hardware
Career Level: experienced
Location/Division: Lowell, MA / BEP
Relocation: No
Posted Date: 12/18/2009
Close Date: ..
C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard and ultimately, you can have an impact on the lives of people around the world.
Apply for this position
* Refer a friend to this job
More information about this job:
Summary of Position with General Responsibilities:
Were seeking a Senior Hardware Quality Engineer to support product development activities for our capital equipment product line, to assure compliance to all appropriate standards, and ensure that each project is fully supported from development through to production environments. Youll assist the development team in establishing customer requirements, concept test evaluation, design performance testing, design verification/design validation and design transfer to production. Youll also provide direction to test techs and inspectors, and may also conduct supplier audits and conduct initial evaluation of customer complaints and any attending failure investigations.
Essential Job Functions:
Additional duties include:
* Ensure the team is in compliance with applicable regulatory and company procedures, standards and requirements, and that Design Control requirements are met and compiled in the Design History File.
* Design Assurance responsibilities include the establishment of detailed performance and design specifications, reviewing animal laboratory study data, developing test and inspection methods, designing test and inspection fixtures, participating in risk analyses, performing design verification testing and data analysis, and providing procedural compliance oversight to the team.
* Develop appropriate design and process risk analyses such as DFMEA, Edge of Failure analysis, Design of Experiments and Statistical data analysis in support for medical device development, in addition to test strategies and plans.
* Participate as a team member of a product development team, and in project Design Reviews.
* Complete all design verification testing, including data analyses, findings reconciliation, and final reporting.
* Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans.
Basic Qualifications:
To qualify for this position you should have a Bachelors degree in Electrical Engineering or equivalent (MS and /or MBA are desirable), in addition to a minimum of five (5) years work experience as a Quality Assurance/Control Engineer in a product development setting. Experience in the medical device field is strongly recommended, cardiology experience is a plus. ASQ Quality Engineering Certification required. Experience in GMPs and QSR within the medical device environment including risk management techniques, and intimate knowledge of IEC 60601-1 requirements required, with demonstrated proficiency in basic analog and digital circuit analysis, use of basic electronic test tools, and ability to read and interpret electrical and electronics schematics. Working knowledge of quality tools and statistics, and ability to analyze and write technical reports using statistical techniques are required. Strong problem solving skills ability to work in a matrix team setting are key.
/Category:, Job ID:, Standard Title:, Career Level:, Location/Division:, Relocation:, Posted Date:, Close Date:">
Industry Title
/Category: Medical Device / Quality
Job ID: 2009-4024
Standard Title: Sr. Quality Engineer - Hardware
Career Level: experienced
Location/Division: Lowell, MA / BEP
Relocation: No
Posted Date: 12/18/2009
Close Date: ..
C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard and ultimately, you can have an impact on the lives of people around the world.
Apply for this position
* Refer a friend to this job
More information about this job:
Summary of Position with General Responsibilities:
Were seeking a Senior Hardware Quality Engineer to support product development activities for our capital equipment product line, to assure compliance to all appropriate standards, and ensure that each project is fully supported from development through to production environments. Youll assist the development team in establishing customer requirements, concept test evaluation, design performance testing, design verification/design validation and design transfer to production. Youll also provide direction to test techs and inspectors, and may also conduct supplier audits and conduct initial evaluation of customer complaints and any attending failure investigations.
Essential Job Functions:
Additional duties include:
* Ensure the team is in compliance with applicable regulatory and company procedures, standards and requirements, and that Design Control requirements are met and compiled in the Design History File.
* Design Assurance responsibilities include the establishment of detailed performance and design specifications, reviewing animal laboratory study data, developing test and inspection methods, designing test and inspection fixtures, participating in risk analyses, performing design verification testing and data analysis, and providing procedural compliance oversight to the team.
* Develop appropriate design and process risk analyses such as DFMEA, Edge of Failure analysis, Design of Experiments and Statistical data analysis in support for medical device development, in addition to test strategies and plans.
* Participate as a team member of a product development team, and in project Design Reviews.
* Complete all design verification testing, including data analyses, findings reconciliation, and final reporting.
* Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans.
Basic Qualifications:
To qualify for this position you should have a Bachelors degree in Electrical Engineering or equivalent (MS and /or MBA are desirable), in addition to a minimum of five (5) years work experience as a Quality Assurance/Control Engineer in a product development setting. Experience in the medical device field is strongly recommended, cardiology experience is a plus. ASQ Quality Engineering Certification required. Experience in GMPs and QSR within the medical device environment including risk management techniques, and intimate knowledge of IEC 60601-1 requirements required, with demonstrated proficiency in basic analog and digital circuit analysis, use of basic electronic test tools, and ability to read and interpret electrical and electronics schematics. Working knowledge of quality tools and statistics, and ability to analyze and write technical reports using statistical techniques are required. Strong problem solving skills ability to work in a matrix team setting are key.
