Manufacturing Engineer -2nd Shift

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The Manufacturing Engineer will be responsible to work with the development and manufacturing teams to bring new devices to manufacturing. This position will involve extensive team interactions with a variety of disciplines across the Redwood City site, including engineering, quality, marketing and business leadership. General responsibilities of this position will include hands-on process development and validations, documentation of process and material and updating of design history files.
The Manufacturing Engineer will be responsible for the development and to provide hands on interface with the implementation of process improvements to improve the device manufacturability and reliability as related to the manufacturing operation. The Manufacturing Engineer will be required to make improvements to all processes related to manufacturing (tooling, line layout, quality and costs).
Proven and demonstrated record of process improvements
o Hands on activities
o Mentored technicians
o Works with minimal guidance
Six Sigma Green Belt training or equivalent.
Minimum of two years Medical Device Background
o Has execute or been responsible for the following
DOE's
Equipment qualification / Software Validation (IQ/OQ/PQ)
Process validation (PV)
Gauge studies
Manufacturing instructions
2-5 years in manufacturing, plus a BS in Manufacturing or Engineering
o Demand flow / Lean manufacturing hands on working knowledge
o Proficient in statistics
o Efficient in tolerance analysis
Back ground in the design of fixtures, gauges and semi automated equipment
o Proficient in CAD design (Solid Works)
Team member
o Work to predetermined schedules
o Status reports
o Problem solving techniques
This position will also have the responsibility to guide technicians in assessment, data gathering and improvement process, as well as interface with vendors. Critical to responsibilities is to support efforts in validations related to processes and equipment in accordance with FDA and ISO guidelines. This position will work in conjunction with new product development, quality and manufacturing teams as well as other technical associates.

Qualifications
Must have 2-5 years in manufacturing, plus a BS in Manufacturing or Engineering and two plus years experience in medical device development and manufacturing, particularly catheter or device based technologies is preferred. Experience with Nitinol material a plus. Other requirements include a solid knowledge of engineering fundamentals, work independently, demonstrated excellent communication skills, both written and oral. Must have proven knowledge of experimental design and the ability to apply this knowledge to product design and manufacturing, knowledge of fundamentals of statistics, and working understanding of GMP and ISO 9000 requirement. Travel requirements approximately 10%.
Bachelor's degree in engineering or related field



Abbott welcomes and encourages diversity in our workforce. EEO/AA

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