Sr. Engr

Position: Sr. Engr.
Job Title:
Sr. Engineer

Duration: 6 Months

Location:
Irvine, CA 92614

Description:

Summary:
The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings and read and interpret blueprints.

The core work is to review "product routers" and associated drawings/requirements and translate them into standardized Inspection Process Instructions (IPI) in an Excel-based router format on the JD Edward. Success will be measured primarily by throughput against a defined workload and timeline. The group aligned on desired candidate profile (independent, project-leading, strong common-sense interpretation of requirements, GDP/documentation discipline), interview process (one interview, maximum two), and near-term logistics with multiple staffing suppliers.

Candidate requirements (senior level definition; regulated environment expectations):

• Regulated industry experience (medical devices/biotech/pharma) is "preferred" but not strictly required.

• Candidate should understand GDP (Good Documentation Practices), including correct redlining/initialing/dating corrections.

• Specific regulatory standards (FDA/ISO/GMP) are explicitly stated as not required.

• Senior-level expectation: ability to work independently; demonstrated experience leading projects from start to finish (not only supporting); ability to troubleshoot and handle "black or white" documentation/interpretation situations.

• Emphasis repeated on "common sense" and practical interpretation as a differentiator.

• Conclusion:
Target is a senior, independent, end-to-end project lead with strong documentation discipline (GDP), while formal regulatory/standard expertise is not mandatory.

Skills:

• Creativity, verbal and written communication skills, analytical and problem-solving ability.

• Team player and detail oriented.

• Ability to make sketches, engineering drawings and common computations.

• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.

• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

• The template-driven IPI creation is presented as straightforward; errors are more likely to come from misreading routers/drawings/requirements.

Education/

Experience:



• Bachelor's degree in engineering required.

• 5-7 years' experience required.

Interview process:

• Interview rounds: one interview - maximum two (Virtual)