Patient Specific, Senior Additive Manufacturing Engineer

The Additive Manufacturing Engineer is responsible for executing and supporting day-to-day manufacturing operations of Selective Laser Sintering (SLS) created parts at Paragon 28. This is an ISO 13485–regulated site producing medical products. Scope includes file receipt, build preparation, scheduling support, part finishing, inspection, packaging, and shipping of medical devices. The role also leads engineering tasks and supports overall activities surrounding new product qualifications, process development, and continuous improvement projects. Attention to detail, hands-on problem solving, and the ability to prioritize activities in a dynamic environment are key attributes.  This position is 100% onsite at our Englewood, Colorado location

Essential Responsibilities and Duties

• Prepare, set up, and monitor additive manufacturing builds (SLS).
• Post-process manufactured parts using tools and machinery (e.g., bead blasters, drills, finishing equipment).
• Inspect and validate parts using pin gauges, calipers, and other quality inspection tools.
• Maintain additive manufacturing equipment and shop environment in compliance with ISO 13485.
• Generate build documentation including Device History Records (DHRs).
• Follow and revise/improve existing SOPs and contribute to the creation of new procedures as needed.
• Evaluate failures and recommend process or design adjustments to improve quality and reduce scrap.
• Support engineering teams in bringing new products and manufacturing processes into production through process development and validation.
• Develop, monitor and improve KPIs including lead time and COGS related to the lab
• Participate in continuous improvement activities to increase efficiency and reliability of manufacturing operations.
• Collaborate with cross-functional teams including design engineering, quality, and supply chain.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• 5-7 years of experience in manufacturing or process engineering; additive manufacturing experience strongly preferred.
• Hands-on experience with manufacturing equipment, post-processing, and inspection tools.
• Experience with Equipment Validation activities and development and execution of IQ/OQ/PQ.
• Proficiency with CAD/CAM software for manipulating files and preparing builds.
• Knowledge of ISO 13485 or other regulated industry requirements (medical device, aerospace, etc.).
• Experience with additive manufacturing processes, particularly SLS, preferred.
• Familiarity with SAP or similar ERP systems a plus.
• Proficiency in Microsoft Office applications (Outlook, Excel, Word).
• Strong communication and teamwork skills.
• Familiarity with Lean and Six Sigma is a plus.