Senior Manufacturing Engineer

Requirements

• Design, document, assemble, qualify and introduces production assembly/test/inspection fixtures and equipment.
• Strong CAD skillset with vision for electro-mechanical fixtures design and implementation.
• Takes ownership of new catheter products during pilot production phase through successful and sustained project launch.
• Provides product and process DFM (Design for Manufacturing) input to Product Development Engineering to enhance manufacturability and product cost.
• Creates an efficient manufacturing assembly line, specifying and/or refining BOMs, workflow processes and detailed MPI work instructions.
• Uses the Agile ACCS creating and modifying BOM’s, Travelers, EFTs and MPIs including ECO/NCO/MCO writing, reviewing and implementation.
• Designs and creates production equipment, fixtures and tests as needed to build the production line either internally or as needed at suppliers.
• Provides training and support to production technicians.
• Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions (VR’s PL’s and EE’s).
• Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.
• Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining of supply chain.
• Mentors and sets project tasks for Manufacturing Engineers on their specific project team and on other teams as needed to further company expertise & effectiveness.

Benefits

• Market-competitive compensation package
• Benefits
• Equity