Manufacturing Engineer I - Development

General Summary The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and that support continuous improvement in production.  Project opportunities are designed to develop professional work knowledge and abilities and to support the efforts and projects that have global importance to the success of the business.  Area of work involves manufacturing processes with interaction between production and cross-departmental engineering groups in resolving problems encountered on the production floor and across the business. Evaluates, selects, and applies exciting engineering techniques, procedures, and criteria, using judgment in developing and implementing adaptations and modifications on the production line and to quality systems.   
Specific Duties and Responsibilities •Solve problems and implement innovative solutions. * •Execute detailed root cause analysis and recommend vetted solutions. * •Communicate and explain problems and solutions cross-functionally and interdepartmentally. * •Approach problems from a detail-oriented perspective. * •Support production; Creating and maintaining product and process documentation; Monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield, efficiency, and/or throughput. * •Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line. Perform equipment qualifications. * •Test processes, equipment, raw materials, and product. Perform process validations. Author protocols to execute tests and write reports and make conclusions and/or recommendations based on test results * •Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project. * •Develop specifications of a product, process, or piece of equipment. * •Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience. * •Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans. * •Participate in project planning and scheduling. * •Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation. * •Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *  •Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *  •Ensure other members of the department follow the QMS, regulations, standards, and procedures. *  •Perform other work-related duties as assigned. *Indicates an essential function of the role
Position Qualifications Minimum education and experience:   •Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree, or an equivalent combination of education and experience
Additional qualifications: •1+ year relevant engineering experience preferred •Engineering experience in a manufacturing environment recommended, medical device industry preferred   •Excellent written, verbal and interpersonal communication skills required  •Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired •Proficiency in Word, Excel, PowerPoint, Access and other computer applications required
Location and Pay Alameda, CA $80,000 to $105,000
Working Conditions •General office, laboratory, and clean room environments. •Willingness and ability to work on site.  •Potential exposure to blood-borne pathogens •Requires some lifting and moving of up to 25 pounds •Must be able to move between buildings and floors.  •Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.   •Must be able to read, prepare emails, and produce documents and spreadsheets.    •Must be able to move within the office and access file cabinets or supplies, as needed.  •Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.