What You’ll Work On

• 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 inter-departmentally
• Approach problems from a detail-oriented perspective
• Suggest independent recommendations for project approach, scope, and tactics
• Support production needs
• Create and maintain product and process documentation
• Monitor process and equipment performance and identify and implement process improvement activities to increase/optimize yield
• Design fixtures, acquire off-the-shelf tooling and equipment, and implement new fixturing on the production line
• 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
• Comply with quality system regulations, standards and procedures
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Ensure other members of the department follow the QMS, regulations, standards and procedures.
• Perform other activities requiring knowledge of principles and techniques commonly employed in the specific area of projects.

What You Bring

• A passion for tackling and solving technical problems preferred
• The ability to communicate complex issues in a clear, compelling manner, both orally and in writing preferred
• Proven work history of growing within an organization, learning its systems, and showing initiative preferred
• Proven track record of solving problems creatively preferred
• Medical device experience strongly preferred
• Proven knowledge of FDA regulations, lean manufacturing, and/or materials and manufacturing processes preferred
• BS degree in Mechanical, Biomedical, Chemical, or Materials Engineering, or a related discipline required

Working Conditions

• General office environment. Business travel from 0% - 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.


• Alameda, CA
• Starting Base Salary is $80,330.00/year to $104,780.00/year.
• Individual compensation will vary over time-based on factors such as performance, skill level, competencies, work location and shift.