Description

• Develops and Executes Process Validation Strategies for EOL including Cleaning and Packaging: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment. • Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. • Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends for process improvement. • Collaborates Cross-Functionally: Works with Manufacturing, Quality Assurance, Engineering, and other teams to implement cleaning strategies, resolve issues, and provide technical support. • Leads continuous improvement initiatives, manages change controls, troubleshoots cleaning problems, and ensures proper documentation and training. • Creating, maintaining, and improving controlled technical documents such as prints, procedures, bills of materials, and routers. • Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, molding, etc. • Conducting feasibility study to estimate a product cost and analyze capital equipment, capacity, and capability requirements • Establishing and improving process methods that meet performance and quality requirements • Developing and executing project plans and schedules for work activities • Communicate (written and verbal) direction and project plans with appropriate personnel from other departments. • Evaluating multiple options to select the most appropriate processes and machining methods • Execute equipment qualification or process validation project(s) Education: • Minimum B.S. degree from an ABET-accredited school (or global equivalent) in one of the following engineering disciplines • 2-4 years of experience: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering. Medical device, particularly the Orthopedic industry, experience preferred

Key Skills

Education

Bachelor's degree