Manufacturing Engineer III

Job Posted 4/9/2022
Bio-Rad Laboratories, Inc.
5731 W. Las Positas Blvd
Irvine, CA
United States
Category BioTech
Job Description

Knowledgeable in troubleshooting and support of high volume liquid filling either in formulation or fill within a medical device environment

Responsibilities

- Evaluate mechanical situations that could lead to non-conforming material and conduct evaluation and suggest and implement methods to prevent reoccurrence.

- Lead investigations and troubleshooting activities to minimize nonconforming materials and optimize production efficiency

- Review engineering design files (CAD drawings, technical specifications, component spec sheets, etc.) for accuracy and manufacturability

- Design or justify new equipment (fixtures, gages, semi-automatic machines, automatic machines, etc.) and processes for new and existing products.

- Create and execute process validations and capability studies.

- Create, review, and maintain SOPs and Work Instructions.

- Travel up to 10% both domestic and international.

- Special manufacturing projects, and other duties as assigned     

Qualifications

- Bachelor's Degree in Engineering/ Scientific field with minimum of 7 years’ industry experience in related industry required.

- Master's Degree in Engineering is highly desirable.

- Proven expertise in usage of MS Office Suite, Solid Works or equivalent, Computer Aided Design (CAD) or ProE experience preferred.

- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.

- Previous experience working with lab/industrial equipment required.

- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.

- Strong problem-solving, organizational, analytical, and critical thinking skills.

- Knowledge of filtration, formulation, automation, machining, and fabrication processes preferred.

- Experience with lean principles, six sigma, and GMP required

- Experience with a ERP system, SAP preferred

- Experience working within a medical device or highly regulated environment required

- Broad knowledge of manufacturing processes, large capex projects, and assembly fixture development.

Employer