About Us At
St. Jude Medical every one of us plays a role in our collective ability
to save and improve lives. As an organization, we want to continue to
grow and lead our industry in changing the way the world views the
treatment of expensive, epidemic diseases. By seeing things from a
different perspective, using our imagination, leading with character,
and working with passion, we all have a role to play in making what we
do possible. Are you ready to join us? We are an Equal
Opportunity/Affirmative Action Employer.
Description
Job Summary:
The Senior Automated Test Engineer participates in the
design, development, verification, validation, and technical support for
automated test systems used in the production of electronic medical
devices for St. Jude Medical’s Implantable Electronic Systems Division
(SJM-IESD) in Plano, TX. This person has an educational background in
Electrical Engineering, with hardware and software design experience in
test automation. Responsibilities include: the coordination and
execution of activities and deliverables associated with test system
requirements, design, verification, valiation, process validation, and
test method validtation. Additional responsibilities include:
technical root cause analysis and troubleshooting support related to
both test system and product performance during day-to-day production
operations.
Key areas of cross-functional focus include: hardware and
software test system design and integration, test coverage analysis,
risk assessments, validation plans and reports, monitoring and trending
test system performance, technical troubleshooting and preventive
maintenance support, and developing detailed procedures and detailed
work instructions for operators and technicians who use the test
systems.
Major, On-Going Responsibilities:
• Interface with Product Development teams to generate test
plans, test requirements, test specifications, and other relevant
documents required to design, develop, verify, and validate automated
production test systems
• Attend internal customer reviews for improvement of
automated test hardware and software to increase testing yield and
throughput
• Develop system architecture and relevant documentation, including hardware and software design and integration
• Collaborate with Manufacturing Engineering, Quality
Engineering, and production personnel to generate and implement test
system improvements based on monitoring and trending of system
performance
• Participate in the design, development, and documentation of test cases for new or existing products
• Provide production support for the automated testing of
SJM-IESD products including (but not limited to): troubleshooting
electronic and electro-mechanical failures, assembly and test process
improvements, replacement of obsolete components, and identification /
correction of design weaknesses
• Participate in the review of new product designs for
manufacturability including (but not limited to) circuit designs, PCB
layouts and panel formats, and design for ease of assembly and test
• Supervise engineering technicians and mentor entry-level engineers
• Develop and implement manufacturing process flow improvement initiatives
• Provide technical support for internal and external Quality and Procurement activities
• Generate Engineering Change Notifications (ECNs) for the
implementation of new design documentation or revision of existing
design documentation, as required for products in production
• Write protocols and reports for Verification, Validation, and Characterization testing
Experience & Training:
• At a minimum a Bachelor’s degree in Electrical Engineering or equivalent
• At least 5+ years experience in developing and supporting test systems/solutions
• At least 5+ years of experience specifying and integrating
test hardware. Experience with wireless testing, accelerometer/motion
control, and machine vision are a plus.
• At least 5+ years of experience designing test fixtures with careful consideration to signal integrity.
• At least 5+ years of experience of test software
development including software architecture, test executives, and test
methods using LabVIEW, LabWindows, C/C++, C#, Perl, TCL, etc.
• A broad knowledge of measurement and control principles is required
• Medical device experience preferred – Knowledge of FDA Quality System Regulations 21 CFR Part 820 and ISO 9001 / 13485
• Strong analytical, problem solving, and troubleshooting skills
• Working knowledge of Gage R&R and statistical process control techniques
• Mastery of assembly drawings, schematics, flow charts, spreadsheets and ECN procedures
• Clear, constructive, and effective communication with
co-workers, management, external suppliers and customers to meet project
goals
• Proven problem solving and critical reasoning skills
Other Skills/Characteristics:
• Individual must be highly motivated and resourceful.
Individual must possess excellent interpersonal skills and have
demonstrated ability to motivate technical personnel.
• Exemplary analytical, organizational, written and oral communication skills are a must
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