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.