Manufacturing Engineer

Staffing and Recruiting
Portland, Oregon Metropolitan Area
June 20, 2025
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Job Description

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**Manufacturing Engineer**
–
**Medical Device**
| Only H1B!

**Location**
: Portland, Oregon (Onsite)

We’re looking for a Manufacturing Engineer to join a high-impact medical device project. The ideal candidate will have strong expertise in process validation and injection molding, supporting quality-driven initiatives and new product introductions.

**Must-Haves:**

➡️ 3–5+ years in medical device manufacturing (regulated environment)

➡️ Proven experience with IQ/OQ/PQ validation

➡️ Strong background in injection molding – tooling, mold studies, troubleshooting

➡️ Experience with FDA (21 CFR Part 820) and ISO 13485 compliance

➡️ Proficient in root cause analysis, Cp/Cpk, and documentation

**Preferred Skills:**

✅ Hands-on mold/tool vendor collaboration

✅ Exposure to supplier quality for molding components

✅ Cross-functional team experience (R&D, Quality, Operations)

✅ Strong process improvement mindset (cost, yield, quality).

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