United Spinal Association Jobs

Senior Validation Engineer for Beckman Coulter, Inc. in Chaska, MN to be responsible for assisting in the sustainment of a robust Master Validation Plan and support of the MVP strategies. Train and mentor individuals and validation teams (both formal classroom and informal) to ensure efficiency and compliance to validation regulations and corporate procedures. Evaluate specifications for requirements. Generate test cases and procedures from specifications. Execute test procedures. Apply Danaher Business System tools to make continuous improvements across the business. Education Required: Bachelor's degree in Bioengineering, Mechanical Engineering or related field (willing to accept foreign education equivalent) plus five (5) years of medical device regulated industry and equipment and process validation experience. OR Master s degree in Bioengineering, Mechanical Engineering or related field (willing to accept foreign education equivalent) and three (3) years of medical device regulated industry and equipment and process validation experience. Partial telecommuting position. Skills Required: Experience must include: Working with software, test method, equipment, process and/or design testing methodologies; Application of 21 CFR 820, ISO 13485, and/or GHTF Process Validations; cGMP, ISO, and FDA rules and regulatory requirements and compliance best known methods; Troubleshooting and root causes analysis, failure investigation, process development and continuous improvement in production context; Medical device assembly processes and automated equipment; Training to validation processes and providing guidance to project teams navigating validation strategies; Statistical data analysis and utilization of software such as MiniTAB or JMP; DOE s (design of experiments), SPC (Statistical process control) and lean manufacturing; Development of equipment and process verification and validation protocols, including IQ (installation qualification), OQ (operation qualification), PQ (Performance qualification), and PV (process validation), as well as reports generations compliant with governing standards and quality management systems; Project Management of concurrent projects utilizing Visual Project Management and Daily Management; and Development of new processes and systems to increase process efficiency. Submit resume to arashidian@beckman.com and reference the job title.