Smarter Alloys

Software Engineer

• Responsible for programming, setup and operation of EDM and CNC machining equipment
• Reviewing designs and verifying tooling requirements prior to each job
• Working closely with engineers and designers to ensure and improve part machinability
• Operating multiple CNC milling and EDM machines at a time to meet workorder deadlines
• Responsible for the EDM and/or manual machining of complex & fabricated components with various metals
• Work at a sustained pace and produce quality work
• Perform work accurately
• Ensure equipment maintenance program is maintained and all safety measures and requirements are met
• Ensure department housekeeping is maintained
• Responsible for requesting quotes, creating purchase requests and receiving of materials

CNC/EDM Programmer, Machinist

Compliance

• Own and maintain the ISO 13485 Quality Management System, ensuring ongoing compliance and effectiveness.
• Lead internal and external audits, including ISO audits, customer audits, and regulatory inspections.
• Support regulatory activities for medical device products, including FDA establishment registration and listing.
• Guide regulatory requirements for new product development from concept through commercialization.
• Maintain and improve quality documentation, including SOPs, work instructions, risk management files, and technical documentation.
• Oversee corrective and preventive actions (CAPA), nonconformance management, and continuous improvement initiatives.
• Support supplier qualification, monitoring, and quality agreements as required.
• Collaborate cross-functionally with engineering, production, procurement, and business development teams.
• Train and support internal teams on quality system requirements and regulatory expectations.
• Serve as the primary point of contact for quality and regulatory matters internally and externally.

CNC/EDM Programmer, Machinist

Quality and Regulatory Manager