Manufacturing Engineer II - Equipment

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. The Manufacturing Engineer Equipment II specializes in the design, development, evaluation, selection, and ordering of the equipment that is most appropriate and cost-effective for the manufacture of company products. 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

As assigned by a project team leader or a manager, as self-identified, or as business needs dictate, independently perform any of the following:   

•        Solve complex 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. *

•        Suggest independent recommendations for project approach, scope, and tactics. *

•        Support production; Creating and maintaining product and process documentation; Monitor process and equipment performance and identify and implement equipment-related process improvement activities to increase/optimize yield, efficiency, and/or throughput. *

•        Coordinate the design, development, installation, modification, upgrade, and maintenance of manufacturing equipment. Study equipment performance and reliability. *

•        Provides technical support to the manufacturing equipment repair and process engineering organizations. *

•        Demonstrate an understanding of quality, operational, and financial systems, company products and customer requirements and how the product or project impacts the objectives of the business. Demonstrate an understanding of how other functional groups within the company are impacted by projects at hand and can impact the project or product results.

•        Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line. Perform equipment qualifications. *

•        Test equipment processes. Perform process validations as appropriate. 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 equipment-related process improvement plans*

•        Participate in project planning and scheduling*

•        Train assemblers, quality control and technicians, as necessary, on processes, equipment, and documentation*

•        Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects

•        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

Location and Salary

•   Alameda, CA

•     $92,000 to $121,000

Position Qualifications

Minimum education and experience: 

Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, Industrial Engineering, or related degree, with 1+ years relevant engineering experience, or an equivalent combination of demonstrated performance, education, and experience

Additional qualifications: 

•    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

Working Conditions

General office, laboratory, and cleanroom environments.

·         Willingness and ability to work on site. Business travel from 0% - 5%.

·         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.