Manufacturing Engineer

About This Role

This position will participate in a variety of engineering design functions, provide technical drawings for suppliers and Production Teams, triage failures, and manage improvement projects. This role works cross-functionally with multiple departments to ensure business objectives and customer needs are met. This is an ideal role for a hands-on Mechanical Engineer with Solidworks design experience and good communication skills looking to make an impact in the fight against cancer.

Responsibilities

• Create Solidworks designs and drawing files for new and existing products
• Create Assembly files with complete Bill of Materials
• Create Drawing files using correct tolerances, including GD&T
• Support the PLM Vault system and product lifecycle management requirements
• Help develop and create assembly procedures for new or modified designs
• Work with external vendors to have prototype parts quoted and ordered as needed
• Support the assembly, testing, and documentation of designs
• Lead or support Design Reviews, First Article Inspection Reports, and non-conformance investigations as needed
• Support the part and assembly documentation requirements for the manufacturing and quality systems in accordance with FDA, GMP, ISO, CAP, CLIA requirements
• Apply defined procedures to execute and document changes to existing equipment
• Create, document, and execute protocols to support process or part changes
• Investigate problems, gather facts, analyze data, and draw accurate conclusions
• Troubleshoot and repair equipment
• Support failure analysis investigations, identify root cause analysis with support from more experienced team members, and develop solutions to resolve quality issues
• Support the building and testing of custom equipment
• Provide manufacturing support for the repair center
• Apply technical knowledge to identify opportunities and recommend improvements to existing equipment and processes
• Develop implementation plans and execute assigned tasks
• Lead less complex improvement projects
• Manage time and competing priorities with minimal guidance from leadership
• Communicate project status and resource needs; prepare and present reports
• Follow procedures and maintain detailed records in accordance with FDA, ISO, CAP, CLIA requirements
• Work independently and as part of a team within a matrix organization
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Support and comply with the company’s Quality Management System policies and procedures
• Regular and reliable attendance