Manufacturing Engineer II

DiaSorin•Cypress, CA
•$97,300 - $131,700

About The Position

The Manufacturing Engineer II evaluates and optimizes manufacturing processes to improve product consistency and quality and increase productivity. The role writes and performs validations and validation reports for production equipment as needed, and supports applicable regulations, including FDA and ISO requirements. It works with Production, Technical Support, and other departments to address technical challenges, improve workflows, reduce costs and scrap, and implement manufacturing technology and processes. The position also represents Operations and Manufacturing Engineering on cross-functional new-product teams, supports audits, and may coordinate technician workloads while enforcing applicable EHS policies.

Requirements

  • Bachelor’s degree in an engineering discipline such as Mechanical, Electrical, or Industrial Engineering.
  • With a bachelor’s degree, at least 2 years of related experience in IVD, medical, pharmaceutical, or another related industry; alternatively, with a master’s degree, at least 1 year of related experience in one of these industries.
  • Ability to read, analyze, and interpret general 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 groups of managers, clients, customers, and the general public.
  • Ability to apply advanced mathematical concepts from calculus and statistics.
  • Ability to apply mathematical operations to 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 broad range of technical instructions in mathematical or diagram form and work with abstract and concrete variables.

Nice To Haves

  • ASQ Certified Quality Engineer.
  • Understanding of statistical quality control, statistical process control, and the Corrective Action Process, including 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 manufacturing technology, including automated equipment, using project management tools.
  • Implement new manufacturing technology, including leading validation and PCR efforts and any necessary training, to ensure successful production transition.
  • Coordinate and supervise required process and equipment validations.
  • Improve and implement processes.
  • Participate in cross-functional core teams for new products, representing Operations and Manufacturing Engineering.
  • 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.
  • Delegate and coordinate technician-group workload as needed and enforce EHS policies within the role’s span of control.
  • Perform other duties as assigned.

Benefits

  • Comprehensive health benefits.
  • Retirement and financial wellbeing benefits.
  • Time off programs.
  • Wellbeing support and perks.
  • May be eligible to participate in an annual incentive program, subject to applicable factors.
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