Job Description
Job Title: Manufacturing Engineer
Job Description
This role supports and improves manufacturing operations for regulated medical device products, with a strong focus on process efficiency, product quality, and regulatory compliance. The Manufacturing Engineer works closely with production, quality, and R&D teams to troubleshoot issues, implement process improvements, and support new product introduction from design through validation and full-scale manufacturing.
Required:
+ Bachelor’s degree in Engineering
+ 5+ years in regulated manufacturing (medical device preferred)
+ Experience with process validation (IQ/OQ/PQ)
+ Experience with CAPA, root cause analysis, and non-conformance investigations
+ Knowledge of FDA QSR and/or ISO 13485
+ Experience supporting NPI and process improvements
+ Proficiency with SolidWorks and Microsoft Office
Preferred:
+ Experience with EU MDR
+ ERP or QMS sy...
Job Description
This role supports and improves manufacturing operations for regulated medical device products, with a strong focus on process efficiency, product quality, and regulatory compliance. The Manufacturing Engineer works closely with production, quality, and R&D teams to troubleshoot issues, implement process improvements, and support new product introduction from design through validation and full-scale manufacturing.
Required:
+ Bachelor’s degree in Engineering
+ 5+ years in regulated manufacturing (medical device preferred)
+ Experience with process validation (IQ/OQ/PQ)
+ Experience with CAPA, root cause analysis, and non-conformance investigations
+ Knowledge of FDA QSR and/or ISO 13485
+ Experience supporting NPI and process improvements
+ Proficiency with SolidWorks and Microsoft Office
Preferred:
+ Experience with EU MDR
+ ERP or QMS sy...