Sustaining Engineering Position in Austin,TX

Question

Division: Innovative Neurotronics
Job Title: Sustaining Engineer
Location: Austin, Texas
Contact: Divya Paramesh
Contact Email: [email protected]
Summary:
Provide sustaining engineering support to existing products and participate in improvement projects for increased product reliability, quality and cost reduction. Strong background in medical device system design.   The Sustaining Engineer works with design engineering, test/quality engineering and manufacturing engineers to coordinate product corrective actions and corresponding process improvements when product flaws are discovered.  This position will work effectively in a multi disciplinary cross functional team environment providing project management and technical troubleshooting to resolve performance or reliability issues, execute manufacturing support projects, and organize qualification plans and reports.  The responsibilities include development of software code for test improvements and IQ/OQ testing.
Key Responsibilities:
Provide Electrical Engineering support for revisions to existing products, which improve reliability, yields, cost and functionality to ensure quality requirements are achieved.
Implement root cause analysis to address CAPA issues.
Design test control equipment, software and procedures for testing products.
Produce production ready documentation, which is compliant to regulatory requirements.
Write IQ/OQ for electrical test equipment.
Prepare electrical schematics and detailed drawings in support of assigned duties.
Work with ECM to provide electrical engineering support for electronic, medical products.
Develop SOP documents for work assignments.
Perform design verification and validation activities for electronic, medical products.
Establish performance requirements for new and existing products.
Design, analyze and debug firmware written in C programming language.
Perform analog, digital circuit design and system testing, write test plans, protocols and test summary reports.
Be current with FDA and ISO medical design regulations, processes, etc.
Review and analyze schematics and electrical designs in order to identify opportunities including cost reduction re-design, part obsolescence solutions, design changes for manufacturing and test processes, design changes for better field access and serviceability, etc.
Provide leadership for project cross-functional teams necessary to perform technology studies, product feasibility studies, high level design, component specification and acquisition, and other coordinated project team activities.
Drive corrective action in response to field issues, coordinate platform enhancements, resolve manufacturing obsolescence or quality issues, implement cost reduction programs, and respond to new regulatory requirements.
Lead technical teams as required ( PST, PRT, Corrective Action teams)
Interface with vendors to resolve incoming quality issues
Analyze data and report results clearly and concisely
Generate and review engineering risk assessments and mitigation plans to ensure changes have no unexpected consequences
Resolve escalated manufacturing support projects
Interface with vendors to resolve incoming quality issues.
Additional Responsibilities:
Microsoft Windows and C++ programming language
Experience with timing analysis and simulation tools, such as MATHLAB, LabVIEW and other analytical tools to develop or update test software.
Experience designing low power commercial products that contain embedded microprocessors.
Experience using oscilloscopes, function generators and other test lab equipment.
Demonstrates understanding of test protocol structure and requirements
Working knowledge of  SolildWorks a plus
Process a solid understanding or manufacturing processes and procedures
Can convey technical solutions for areas of competence both to other engineers and to business personnel
Ability to communicate clearly and effectively in both verbal and written media
Experience with component / vendor selection for medical product development.
Experience with Schematic and Layout tools.
Good understanding of the PCB board layout process.
Understanding of the implications re-design suggestions can have on verification and the certification of a Medical devices.
Experience with problem solving and change management  in a regulated environment
Excellent problem identification and innovative thinking skills to design experiments, assess risks, develop solutions and determine verification and validation requirements.
In-depth understanding of design and assembly of electromechanical devices
Understand documentation, electromechanical assembly and manufacturing methods such as circuit board test, both ICT and functional.
Ability to understand and create documentation utilizing PC based system.
Ability to function in a team environment as well as in technical capacities.
Strong communication skills with all levels of technical and operating personnel, both internal and external.
Required Credentials:
8– 10 years experience  
Bachelor's of Science in Electrical Engineering (Advanced Degree a plus); with 10 years of experience in electronic medical device systems manufacturing and sustaining engineering activities. . At least 3-4 years experience in Medical Device design. 
Ability to use CAD programs to create printed circuit board designs with Electronic Contract manufacturer (ECM).
Experience in developing test protocols for design verification and validation.
Working knowledge of cGMP and MDD requirements for medical devices.
Experience with ISO 13485, ISO 9001 and FDA regulations.
Skills:
The preceding information is provided as a brief summary and incorporates typical responsibilities and qualifications of the position. Other related duties or specific criteria not expressly mentioned may be required for a particular vacancy and can be explained by the hiring manager.
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Answer 1

Are you looking for overseas candidates? Do reply. Please find my resume attached.
Regards,
Giridhar Rajan
Automation Engineer
Cruiser Controls
Mumbai, India
Attachments:
CV_Giridhar Rajan.doc ‏50 KB