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 Engineer II to work with our innovative Manufacturing Engineering team in Pleasanton, CA.
The Manufacturing Engineer II will perform moderately complex activities in providing manufacturing engineering support of existing circulatory support products. They will provide technical solutions to a wide range of difficult problems. They will also provide solutions to a variety of technical problems of moderate scope and complexity, will work under general supervision and follow established procedures.
The duties and responsibilities of this position include, but are not limited to, the following engineering activities:
Develop and validate manufacturing processes, including equipment identification, design, installation and validation for electro/mechanical assemblies.
Design product assembly drawings, bill of materials, and component drawings in an ISO-9001/FDA GMP design and document control environment.
Write useful fabrication procedures, QA procedures, and process control documents.
Develop manufacturing process flow diagrams and process validation procedures. Evaluate process capability and identify needs for improvement.
Collect and analyze in-process data to determine areas for process improvement.
Provide technical support to manufacturing and QA to improve productivity and reduce costs.
Work with R&D group to transfer new products into manufacturing.
Provide input and support to Regulatory Affairs for FDA submission and to resolve customer concerns.
Excellent written and verbal communication skills required.
Requires a B.S. in Mechanical, Manufacturing Engineering or equivalent combination of experience and education, M.S. or PhD is desired.
Requires three to six years engineering experience including skills in process development, improvement and validation related to manufacturing electro-mechanical medical devices.
Practical knowledge of DFM, DFX and GD&T principles valuable.
Expertise with root cause analysis, troubleshooting, risk analysis and experiment design is desirable.
Four years of medical device industry experience with ISO/GMP’s.
Requires strong analytical, written and verbal communication skills and the ability to interface with all departments.
Must have good computer software skills with word processing, database management and spreadsheets.
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)....