Manufacturing Engineer II

Diasorin•Cypress, CA

23d

About The Position

Evaluate and optimize manufacturing processes to improve product consistency and quality and increase productivity. Write and perform validations and validation reports for production equipment as necessary, and support applicable regulations, including FDA and ISO requirements. The role works with Production, Technical Support, and other departments to resolve technical challenges, improve processes, implement manufacturing technology, and support new products and audits. It may also coordinate workload for technicians and is responsible for enforcing applicable EHS policies within its span of control.

Requirements

Bachelor's degree in an engineering discipline such as Mechanical, Electrical, or Industrial Engineering.
At least 2 years of related experience with a bachelor's degree in the IVD, medical, pharmaceutical, or another related industry; alternatively, at least 1 year of related experience with a master's degree.
Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, and governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to present information effectively and respond to questions from managers, clients, customers, and the general public.
Ability to apply advanced mathematical concepts from calculus and statistics, including statistical methods such as frequency distributions, test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with abstract and concrete variables.

Nice To Haves

ASQ Certified Quality Engineer.
Understanding of statistical quality control, statistical process control, and Corrective Action Process, and their application in manufacturing for problem identification and resolution.

Responsibilities

Work with Production and Technical Support personnel to identify, isolate, and correct technical challenges to improve product reproducibility.
Improve production processes to reduce costs and decrease scrap.
Research and purchase new manufacturing technology, including automated equipment, using project management tools.
Implement new manufacturing technology to ensure production continues successfully, including leading validation and PCR efforts and necessary training.
Coordinate and supervise required process and equipment validations.
Improve and implement new processes.
Participate on cross-functional core teams for new products, representing Operations and Manufacturing Engineering.
Participate in and support internal and external audits.
Maintain and increase workflow.
Interact with required departments to assist with project completion.
Perform assigned tasks in accordance with applicable EHS regulations and company EHS policies.
Enforce EHS policies within the role's span of control.
Delegate and coordinate technician-group workload as needed.
Perform other duties as assigned.