What are the responsibilities and job description for the Senior Engineer position at TalentBurst, an Inc 5000 company?
Position: Sr Manufacturing Engineer / Sr Process Engineer, Req# 16877-1
Location: Irvine, CA (100% onsite)
Duration: 6 months contract with high possibilities of extension/conversion
Job Description:
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 a 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.
Education and Experience:
Candidate requirements (senior-level definition; regulated environment expectations):
- Bachelor's degree in engineering required.
- 2-7 years of experience required.
- Medical Devices industry experience is highly preferred but not required
- 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.
- Independent, end-to-end project lead with strong documentation discipline (GDP), while formal regulatory/standard expertise is not mandatory.
Top Skills:
- Converting manufacturing paper documentation to digital documentation
- Sampling is going on in the project
- Inspection side skills
- Process sheet
- Sampling plans
- tolerance
- Inspection
- Calipers, drop gauge
- Inspection tools
- GDP, GMP,
Salary : $50 - $60