Description
This role supports and improves manufacturing operations for regulated medical device products, with a focus on process efficiency, product quality, and compliance. The engineer will work cross-functionally with production, quality, and R&D to troubleshoot issues, implement improvements, and support new product introduction.
Must-Have Qualifications
Bachelor’s degree in Engineering or related technical field
5+ years of experience in a regulated manufacturing environment (medical device highly preferred)
Working knowledge of:
FDA QSR
ISO 13485:2016
EU MDR (2017/745)
Hands-on experience with process validation (IQ, OQ, PQ)
Experience with non-conformance investigations, CAPA, and root cause analysis
Strong understanding of statistical process control (SPC) and process improvement
Proficiency with SolidWorks and Microsoft Office (Excel, Word)
Key Responsibilities
Provide engineering support to production and product development teams<...