BSEE / MSEE with Design Assurance exp in #medicaldevice industry ~ we're looking for you in Plano! http://t.co/KVPW4lRFHw
— St. Jude Medical (@SJMjobs) September 24, 2013
Showing posts with label quality jobs. Show all posts
Showing posts with label quality jobs. Show all posts
Tuesday, September 24, 2013
Principal Design Quality Engineer ~ St. Jude Medical - Plano, TX
Tuesday, November 09, 2010
Director, Quality Systems and Operations (St Jude Medical) Plano, TX
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The Director, Quality Systems and Operations serves as the owner of quality system development and deployment for St. Jude Neuromodulation’s (NMD) worldwide operations. The scope of these responsibilities includes direction of quality function operations at the Division’s New Jersey, Portland and Plano sites, as well as the development, implementation and on-going improvement of quality systems across the enterprise.
The Director, Quality Systems and Operations serves as the owner of quality system development and deployment for St. Jude Neuromodulation’s (NMD) worldwide operations. The scope of these responsibilities includes direction of quality function operations at the Division’s New Jersey, Portland and Plano sites, as well as the development, implementation and on-going improvement of quality systems across the enterprise.
Wednesday, August 25, 2010
Manager, Quality Engineering (QA) - St Jude Medical
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Manager, Quality Engineering (St Jude Medical) Plano, TX
Electrical/Software Quality Engineering Manager directs a group of 5 to 10 engineers that are focused on electrical, software, and firmware quality engineering. They will lead a group that are responsible for assuring that electrical devices, firmware, and software developed for use or sale at SJM NMD meets all regulatory and voluntary standard requirements. This includes providing guidance to a group of engineers with experience ranging from 5 years to 25 years.
Manager, Quality Engineering (St Jude Medical) Plano, TX
Electrical/Software Quality Engineering Manager directs a group of 5 to 10 engineers that are focused on electrical, software, and firmware quality engineering. They will lead a group that are responsible for assuring that electrical devices, firmware, and software developed for use or sale at SJM NMD meets all regulatory and voluntary standard requirements. This includes providing guidance to a group of engineers with experience ranging from 5 years to 25 years.
Thursday, July 01, 2010
Sr. Compliance Engineer - St Jude Medical (Plano, TX)
Apply Online
The Senior Compliance Engineer is responsible for minimizing risk to the organization associated with pre and post production efforts under governing domestic and international requirements. This position ensures and helps maintain Compliance vigilance across the organization in compliance to applicable ISO, AAMI, EN, FDA, FCC, CSA type requirements and serves as the focal point for defining Compliance activities. This position helps define, interpret, and/or ensure the use of, and compliance to, appropriate test standards and regulatory requirements that apply to a medical device manufacturer.
Major, On-Going Responsibilities:
• Identify Compliance needs, such as requirements and testing standards to project teams, per product type, per desired country of sale.
• Collaborate with Product Development, Manufacturing, and Product Assurance to build requirements matrices per product type per country per appropriate regulations and to streamline product development efforts by designing and standardize testing protocols as appropriate.
• Lead process improvement efforts related to setting up internal company process related to compliance to required global standards and regulations.
• Lead business process optimization projects for reducing project cost and reducing time to market via standardization techniques.
• Participate in the review of design documentation to ensure that accepted engineering practices, laws and regulations have been met; obtain interpretations of requirements using international St. Jude affiliates as necessary
• Verify technical content in Design, Manufacturing, and Quality System sections of 510K, PMA, and IDE submission applications per appropriate guidelines and regulations within the scope of the submission strategies and plans.
• Provide project management for cross functional customers on compliance projects
• Remains current on present and pending international and domestic regulatory requirements and testing standards through St. Jude resources, training, external seminars, participating in standards committees and reading of technical articles.
Experience and Training:
• Master’s degree preferred. Minimum 5 years related work experience; e.g. as Product Designer / Product Development / Project Manager / Microbiologist / Sterilization Specialist / Engineer Regulatory Affairs / Quality Assurance / Quality Engineering.
• Minimum of 2 years experience in a medical device environment.
• Familiarity or experience with domestic and international medical device requirements (such as with the Medical Device Directives AIMD, MDD, CMDR, JGMP, ISO 13485:2003, ISO 14971, ASTM, Sterilization, Biocompatibility ISO 10993, etc.) is highly desired.
• Product safety experience and familiarity with EN, IEC, CSA type standards is desired
• Experience in designing and/or testing of electrical medical devices preferred
The Senior Compliance Engineer is responsible for minimizing risk to the organization associated with pre and post production efforts under governing domestic and international requirements. This position ensures and helps maintain Compliance vigilance across the organization in compliance to applicable ISO, AAMI, EN, FDA, FCC, CSA type requirements and serves as the focal point for defining Compliance activities. This position helps define, interpret, and/or ensure the use of, and compliance to, appropriate test standards and regulatory requirements that apply to a medical device manufacturer.
Major, On-Going Responsibilities:
• Identify Compliance needs, such as requirements and testing standards to project teams, per product type, per desired country of sale.
• Collaborate with Product Development, Manufacturing, and Product Assurance to build requirements matrices per product type per country per appropriate regulations and to streamline product development efforts by designing and standardize testing protocols as appropriate.
• Lead process improvement efforts related to setting up internal company process related to compliance to required global standards and regulations.
• Lead business process optimization projects for reducing project cost and reducing time to market via standardization techniques.
• Participate in the review of design documentation to ensure that accepted engineering practices, laws and regulations have been met; obtain interpretations of requirements using international St. Jude affiliates as necessary
• Verify technical content in Design, Manufacturing, and Quality System sections of 510K, PMA, and IDE submission applications per appropriate guidelines and regulations within the scope of the submission strategies and plans.
• Provide project management for cross functional customers on compliance projects
• Remains current on present and pending international and domestic regulatory requirements and testing standards through St. Jude resources, training, external seminars, participating in standards committees and reading of technical articles.
Experience and Training:
• Master’s degree preferred. Minimum 5 years related work experience; e.g. as Product Designer / Product Development / Project Manager / Microbiologist / Sterilization Specialist / Engineer Regulatory Affairs / Quality Assurance / Quality Engineering.
• Minimum of 2 years experience in a medical device environment.
• Familiarity or experience with domestic and international medical device requirements (such as with the Medical Device Directives AIMD, MDD, CMDR, JGMP, ISO 13485:2003, ISO 14971, ASTM, Sterilization, Biocompatibility ISO 10993, etc.) is highly desired.
• Product safety experience and familiarity with EN, IEC, CSA type standards is desired
• Experience in designing and/or testing of electrical medical devices preferred
Monday, April 12, 2010
Jobs @ St Jude Medical (Neuromodulation)
Busy week! I'll be targeting my recruiting/sourcing efforts on specific positions within our Quality organization and our Prod Dev (EE) team.
Specifically, I'll keep targeting strong EE candidates for our Sr. Engineer positions (looking for old-fashioned engineers with a strength in hardware design / PCB layout design). And, we've got multiple new Quality positions posting this week. I'll reference them specifically in a new post by mid-week. For now, here's the Quality positions I'm focusing on today:
Quality Control Engineer
Reliability Engineer
Sr. Compliance Specialist
Data Analyst
Specifically, I'll keep targeting strong EE candidates for our Sr. Engineer positions (looking for old-fashioned engineers with a strength in hardware design / PCB layout design). And, we've got multiple new Quality positions posting this week. I'll reference them specifically in a new post by mid-week. For now, here's the Quality positions I'm focusing on today:
Quality Control Engineer
Reliability Engineer
Sr. Compliance Specialist
Data Analyst
Tuesday, April 06, 2010
New Quality Jobs at St Jude Medical
On Friday I'll be posting three new jobs to be located at our HQ in Plano, TX (all our in our Quality organization):
Quality Systems Engineer
Compliance Engineer
Sustainment Engineer
I'll include the job descriptions as soon as they are available - stay tuned.
*follow our jobs on Twitter ~ @dennissmith
Quality Systems Engineer
Compliance Engineer
Sustainment Engineer
I'll include the job descriptions as soon as they are available - stay tuned.
*follow our jobs on Twitter ~ @dennissmith
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