Manufacturing Engineer
Location
Austin, TX
Level
Entry-Level
Department
MedTech
Type
Salary
$74,000 - $123,000
Job Description
Posted on:
2026-01-29
Responsibilities
- Support day-to-day production to meet consumables demand across the company.
- Provide manufacturability input as products move into more mature lifecycle stages.
- Design, test, and implement production fixtures, tooling, workstations, and assembly aids.
- Troubleshoot manufacturing issues, perform root cause analysis, and implement corrective actions.
- Support quality control activities in compliance with Design Control requirements, cGMP, FDA regulations, and internal policies.
- Generate and maintain manufacturing documentation, including work instructions, Device Master Records (DMRs), and Design History Files (DHFs).
- Conduct risk assessments and support mitigation efforts to ensure product safety and reliability.
Job Requirements
- Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Biomedical Engineering, or a related field, or equivalent experience.
- 1+ year of experience in manufacturing engineering or engineering design.
- Experience in Solidworks (preferred), OnShape, Creo, or an equivalent CAD program.
- Hands-on experience physically building hardware (machining, fabrication, soldering, assembly, prototyping, etc.).
- A genuine interest in manufacturing and passion for learning.
- Familiarity with ISO 13485, FDA 21 CFR Part 820, or other regulated manufacturing standards (preferred).
- Strong interest in manufacturing small, safety-critical assemblies where precision and quality are paramount.
