Job Title: Manufacturing Engineer III
Location: 829 Towne Center Drive, Pomona, CA 91767
Duration: 6+ months (possible extension)
- The Manufacturing Engineer III is part of the Tox business unit and is located at the Immunalysis site in Pomona, CA. The main function of the position is to develop and improve manufacturing processes by studying products and manufacturing methods.
- Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.
- Evaluate manufacturing processes and ensure software validation program maintains compliance to applicable regulations and company policies.
- Writes and coordinate protocols that challenge critical parameters related to installation, operation, and performance of the related facilities, utilities, computer systems or equipment.
- Participates in risk management activities.
- Generate contamination controls and cleaning procedure for the facility to control for possible debris or particulate contamination.
- Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
- Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.
- Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.
- Provides manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
- Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
- Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
- Provides manufacturing engineering information by answering questions and requests.
- Maintains product and company reputation by complying with government regulations.
- Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
- Completes design and development projects by training and guiding technicians.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
- Contributes to team effort by accomplishing related results as needed.
- Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
- Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
- Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
- Perform other duties & projects as assigned.
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
- Bachelor's degree in engineering or related discipline required.
- 5-7 years' related experience required.
- Experience facilities, utilities within medical device manufacturing.
- Work experience in a highly regulated industry; medical device
- Understand warehousing and distribution requirements.
- Equipment validation.
- 21 CFR 820 and ISO 13485 knowledge
- Advanced proficiency with Microsoft Suite (Outlook, Word, Excel, Power Point), Database software and Laboratory.
- Driven for Results
Thanks & Regards,
Talent Acquisition Specialist
Phone: 414-203-8334 Ext: 7192
100 Manpower Place, Milwaukee WI 53212