Manufacturing Engineer

We are seeking a Manufacturing Engineer New Product Introduction (NPI) to join our this role you will develop implement and maintain engineering methods and systems to meet site-specific customer and regulatory requirements. You will proactively communicate initiatives that support departmental plant and corporate operational goals. As an engineering representative you will provide support and guidance for new product transfers through internal volume production suppliers and customer locations. Additionally you will drive new product introductions to ensure alignment with customer specifications and delivery Youll Do:Applies advanced troubleshooting and root cause analysis methods to solve problems with documented supports the operations supports the qualification and validation activities associated with manufacturing equipment and special and implements robust production processes and methods assuring that process capabilities are adequate to support business work instructions and necessary documentation to train associates and sustain manufacturing with cross-functional teams (customer service manufacturing quality scheduling purchasing) to develop and coordinate new product introductions and sustain existing as the primary liaison between customers and internal teams for both new and legacy projects ensuring alignment on goals and project quotes including cost estimation pricing margins and alignment with corporate financial new product projects as project manager ensuring quality on-time delivery and compliance with ISO FDA and customer and manage Device Master Records (DMR) manufacturing processes and design-for-manufacturing initiatives to optimize cost quality and post-production activities and manage Non-Conformance Material Reports (NCMR) to ensure product quality and continuous improvement initiatives and provide support to quality operations and purchasing teams to meet corporate Youll Need:Bachelors degree in an engineering discipline with 2 years of manufacturing experience or equivalent combination of education and in an ISO 13485 ISO 9001 or medical device manufacturing environment background demonstrating proficiency with problem solving and root cause analysis have the ability to effectively work and communicate within a team and cross functionally to expedite completion of critical project understanding and ability to lead Lean or TOC improvement customer service skills via written and verbal communication experience with Solidworks or similar CAD knowledge of drafting standards and geometric dimensioning and with MasterCam Esprit Partmaker or similar CAM systems is a plus.