Job Opportunity:
We are seeking a skilled Manufacturing Engineer to lead our engineering department.
Role Overview:
This role involves leading Engineering Change Notices (ECNs), managing validation activities, and overseeing First Article Inspection (FAIR) reporting.
The Role:
* Lead ECNs and ensure smooth implementation.
* Manage validation activities and oversee FAIR reporting.
* Support New Product Introductions (NPI), acting as a project lead and working closely with customers and cross-functional teams.
* Provide CAD support, prepare technical drawings, and design jigs and fixtures.
* Define and optimize manufacturing and assembly processes, including external subcontract processes.
* Ensure compliance with Standard Operating Procedures (SOPs) and production system requirements.
* Drive continuous improvement initiatives to reduce waste and enhance efficiency.
* Stay current with new technologies and best practices within manufacturing.
Requirements:
Bachelor's degree in Engineering required. 3-5 years' experience in medical devices or another highly regulated industry (pharma, aerospace, automotive) preferred. CAD experience (Solid Works or equivalent) necessary. Familiarity with investigative techniques and statistical analysis tools (e.g., Minitab) desirable.
Why Work With Us:
Join a forward-thinking organization at the forefront of advanced manufacturing, working on innovative projects that directly impact patient outcomes.