Senior Manufacturing Engineer: Process & Validation

RXinsider LTD.; Irvine (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD is seeking a Manufacturing Engineer in Irvine, CA to support and optimize manufacturing processes, equipment, and methods in an FDA-regulated setting. The role partners with QA, R&D, and Operations to enable new product introductions, process validations, and continuous improvement.

Requirements include a mechanical engineering degree with 6–8 years (or 2–6 years with a Master’s), experience in FDA manufacturing, and strong English writing skills.

Qualifications

• Bachelor's degree in Mechanical Engineering or a related engineering discipline with 6-8 years of relevant experience, or Master's degree with 2-6 years of relevant experience.
• Experience working in an FDA-regulated manufacturing environment.
• Strong partnership and collaboration skills with Quality Assurance and R&D teams.
• Fluent English communication skills, both written and verbal.
• Strong technical writing and documentation skills.

Responsibilities

• Establish and maintain manufacturing documentation, procedures, drawings, and technical records.
• Develop, implement, and improve manufacturing processes and methods to enhance operational performance.
• Lead transfer of new products from R&D into manufacturing.
• Train production operators on manufacturing processes, equipment, and procedures.
• Lead manufacturing projects and process improvement initiatives.
• Maintain technical services and facilities performance metrics.

Skills

FDA-regulated environment

Collaboration with QA/R&D

Technical writing

Education

Bachelor's degree in Mechanical Engineering or related field

Master's degree in Mechanical Engineering or related field

Tools

SolidWorks 3D CAD

Microsoft Project

Job description

BD is seeking a Manufacturing Engineer in Irvine, CA to support and optimize manufacturing processes, equipment, and methods in an FDA-regulated setting. The role partners with QA, R&D, and Operations to enable new product introductions, process validations, and continuous improvement.

Requirements include a mechanical engineering degree with 6–8 years (or 2–6 years with a Master’s), experience in FDA manufacturing, and strong English writing skills.