Pioneering Therapies, Transforming Lives . What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. We have an incredible opportunity for a Manufacturing Electrical Engineer III, NPI to work with our innovative Engineering team in Pleasanton, CA.
The Manufacturing Electrical Engineer III, NPI will perform complex activities in providing manufacturing engineering support of existing circulatory support products and the development/transfer into manufacturing of new products. Provides technical solutions to a wide range of difficult problems. Works under only general direction. Independently determines and develops approach to solutions.
This position is responsible for, but not limited to, the following:
Work with cross-functional teams to transfer new products efficiently and effectively into manufacturing.
Provide critical assessments of new product/component designs regarding DFM/DFA/DFT principles.
Work with various internal and external organizations as required developing manufacturing processes or resolving technical issues w/ on-going products.
Improve/design existing/new equipment/fixtures/gauging based on product and manufacturing/QA/R&D requirements.
Develop and validate manufacturing processes (including identification, design, installation and validation of equipment) for fabrication of products in a clean room environment.
Review technical drawings for appropriate dimensions and tolerances for the application.
Develop product/PCBA drawings, bill of materials and component drawings.
Develop effective fabrication, in-process control, and final quality test procedures.
Develop manufacturing process flow diagrams, pFMEAs and process validation procedures.
Aid in the selection, evaluation and ramp up of contract manufacturers.
Perform process characterization studies.
Collect and analyze in process data to evaluate capability and determine areas for process improvement.
Drive process improvements and validations through manufacturing implementation.
Provide technical support to manufacturing and QA to improve productivity and reduce costs.
Provide input and support to Regulatory Affairs for FDA submission and to resolve customer concerns.
Participate as a manufacturing lead and/or support a lead on cross-functional core teams.
Evaluate process capabilities, cycle times, yield, throughput, labor standards, and environmental impact.
Participate in vendor evaluations re: manufacturing capability and capacity, engineering support and overall process quality controls.
Requires a B.S. in Electrical Engineering.
Requires five to eight years engineering experience including skills in new product introduction, process development, improvement and validation related to manufacturing electro-mechanical devices.
Requires strong analytical, written and verbal communication skills and the ability to interface with all departments.
Industry experience with FDA design controls for medical devices (ISO/GMP) strongly preferred.
Industry experience with implantable electronics and Li-Ion batteries a plus.
Experience with CAD design, SPC, DOE, CMM, six sigma concepts, and/or project management skills a plus.
Ability to use basic electrical test equipment (Oscilloscopes, DMMs, Power Supplies, Frequency Generators, etc.)
Good organization and time utilization skills. Knowledge of Microsoft programs (Word, Excel, MS Project, Powerpoint).
Why work for us?
For more than 30 years, Thoratec has been committed to developing advanced medical technologies to improve patient survival and quality of life. Thoratec provides the broadest mechanical circulatory support portfolio to treat the full range of clinical needs. From acute to chronic heart failure, Thoratec offers proven device-based therapies to provide a new beginning for patients and their families. We value people who are passionate about collaboration, creativity, and quality. We give back to our community and help people live healthy lifestyles through support, education, involvement, and participation.
Thoratec employs more than 700 people worldwide. We are based in Pleasanton, California, with facilities in Burlington and Waltham, Massachusetts; Sunnyvale and Rancho Cordova, California; Cambridgeshire, UK; and Zurich, Switzerland.
Thoratec Corporation is an Affirmative Action/Equal Opportunity Employer.
Thoratec Corporation (Thoratec) is a manufacturer of mechanical circulatory support products for use by patients with heart failure (HF)....