Our client, an emerging leader in the field of in vitro diagnostics, has an immediate opening for a Senior Consumables Manufacturing Engineer. This role will support our reagent consumables manufacturing operation and is responsible for promoting product quality and continuous process improvement.

Responsibilities:

• Work with the Manufacturing team to determine appropriate quality metrics for all manufacturing processes and report on them as appropriate
• Assist with training of personnel in the proper usage of manufacturing equipment and troubleshooting of equipment as necessary to minimize down time
• Develop new fixturing or improve existing equipment as needed to improve production efficiency and product quality
• Author and execute IQ/OQ and validation protocols for manufacturing equipment
• Assist in driving timely completion of Non-Conformance Material Reports while preventing repeat occurrences
  
• Collaborate with Manufacturing Management to generate quality reports that track cycle times, yields/quality rates, and evaluate trends through Pareto charts for various quality system and product performance metrics
• Troubleshoot process problems, identify root causes, coordinate implementation of corrective actions, and verify effectiveness
• Support process and product-related deviation activities including tracking and trending
• Maintain positive and effective communication and collaboration with all levels of the team and outside partners and vendors
• Other tasks as needed to support organizational goals and objectives

Requirements: 

• Bachelor’s Degree in engineering or science related discipline required
• Minimum of 5 years of relevant experience in an FDA regulated environment required, ideally within medical device, in vitro diagnostics, or pharma industry
• ASQ or Six Sigma Certification or equivalent is desired
• Working knowledge of FDA IVD regulations and guidelines and/or experience with FDA and/or notified body audits strongly preferred
• A working understanding of clean rooms, associated equipment, maintenance, and operating standards
• Must be familiar with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (cGLP)
• Experience working within FDA Quality Systems compliant with EN ISO 13485, ISO 14971, IVDD, and 21CFR Part 820
• Must be able to read and interpret engineering drawings and component specifications and apply appropriate metrology methods to inspect the components associate with these drawings
• Must be familiar with relevant inspection techniques and equipment
• Must have strong technical writing, statistical sampling, and data analysis skills; proficient with Microsoft Excel
• Must demonstrate sense of ownership and accountability. Works with a results-oriented approach, a sense of urgency, uses sound judgment, and has strong attention to detail
• Familiarity with Solid Works is desired
• Ability to communicate with team members at all levels and be comfortable both challenging and influencing others and being challenged by others without getting defensive