Operations Engineer

Cerapedics has two drug-device products approved by the FDA powered by Cerapedics’ proprietary P-15 Osteogenic Cell Binding Peptide: PearlMatrix™ Bone Graft for all major lumbar interbody surgical approaches and i-FACTOR® Bone Graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. A typical day will include collaborating with cross-functional teams and suppliers, evaluating proposed material and process changes, coordinating testing activities, analyzing technical data, and driving projects through the change control process.

ABOUT US Cerapedics is a global, commercial-stage orthopedics company that is dedicated to redefining the path to bone repair by healing bones faster and at higher rates, so all patients can get back to living their fullest lives. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide. Cerapedics has two drug-device products approved by the FDA powered by Cerapedics’ proprietary P-15 Osteogenic Cell Binding Peptide: PearlMatrix™ Bone Graft for all major lumbar interbody surgical approaches and i-FACTOR® Bone Graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. Cerapedics is headquartered in Westminster, Colorado. OVERVIEW Healing lives through bone repair – this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as a Operations Engineer in our Westminster office. In this role, you will contribute to our mission by supporting the processes, materials, equipment, and systems that enable the consistent production of innovation bone repair technologies that help improve patients' lives. As an Operations Engineer working on the Technical Operations team, you will be empowered through meaningful work and career development to help drive projects through our change control process. A typical day will include collaborating with cross-functional teams and suppliers, evaluating proposed material and process changes, coordinating testing activities, analyzing technical data, and driving projects through the change control process. POSITION OBJECTIVES: Responsible for ensuring that any changes (e.g., raw materials, regulations, equipment, process) meet requirements (e.g., FDA, BSI, quality systems). Ensure changes including raw materials from vendors, processes, equipment change, etc. meet requirements in accordance with internal procedures. Monitor external standard changes in regulations and standards and ensure that we have done all the work to ensure that our products are compliant. Support the Engineering Change Control Process. Ensure that we adequately assess changes in collaboration with key stakeholders. Help improve key processes to ensure continuity of supply. Actively participate in management of appropriate engineering change controls and reviews. Makes impact on proposed solutions on operational processes and procedures. Promptly and accurately communicate project status, risk analysis, and risk mitigation plans. Effectively answer questions in detail and produce clear and concise summaries for projects to the leadership/management team. Evaluate changes and execute appropriate qualification activities. Ensure that the appropriate documentation is completed in accordance with the quality system. Compensation details: 95000-136000 Yearly Salary PI258320b4dbf8-25448-417579015c143e31-5e48-4549-b638-05792d185386