Senior Manufacturing Engineer
6 days ago
About Us:
Join a leading medical device company focused on innovation and improving patient outcomes. We are seeking a Senior Manufacturing Engineer to optimize processes and ensure high-quality production standards.
Key Responsibilities:
- Lead process development and improvement for medical device products.
- Collaborate with R&D to ensure manufacturability (DFM) and process efficiency.
- Manage process validation (IQ, OQ, PQ) and support new product introductions.
- Implement Lean Six Sigma methodologies to drive continuous improvement.
- Ensure compliance with ISO 13485, FDA regulations, and GMP standards.
- Provide technical leadership and mentorship to junior engineers.
Qualifications:
- Bachelor’s in Mechanical, Manufacturing, or Industrial Engineering (Master's preferred).
- 7+ years of manufacturing engineering experience, preferably in medical devices.
- Strong knowledge of FDA, ISO 13485, and GMP regulations.
- Experience with process validation and Lean Six Sigma methodologies.
- Proficiency in CAD and ERP/MRP systems.
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