Senior Process Engineer

Identifies key opportunities to develop and implement equipment and/or process enhancements that will improve efficiency, product yield, and safety. Identify, plan, and implement projects related to product and process improvement, ensuring alignment with strategic goals. Design and implement experimental protocols applying statistical tools to enhance manufacturing processes and product performance. Analyze current processes to identify key opportunities for equipment and process enhancements that improve efficiency, yield, and safety. Develop detailed documentation for process validation, project management, business case proposals, and root cause problem solving while ensuring compliance with industry regulations and internal standards. Monitor and analyze production data to identify trends and provide actionable insights for continuous improvement. Lead Six Sigma initiatives to drive process optimization and problem resolution within production environments. Support NPI launch by completing process characterization work, process challenge testing, process capability and stability runs, to qualify new product & processes and achieve annual business plan. Engage with personnel in the identification and resolution of corrective/preventative actions that address any process quality related manufacturing issues.

Qualifications

• Bachelor’s degree in Engineering required. Masters degree is preferred.
• A minimum of 4 years of relevant work experience is required.
• Project management experience in an engineering environment.
• Strong analytical problem-solving skills with experience in data analysis and visualization.
• Excellent written and oral communication skills; ability to present complex information clearly and concisely.
• Strong organizational skills
• Prior experience using Minitab, JMP, or other analytical tools for statistical analysis and effective data visualization.
• Demonstrated ability to work collaboratively within multi-functional teams and influence partners at all levels.

Preferred experience:

• 2+ years experience in an engineering function in FDA environment preferred
• Six Sigma certification or extensive experience applying Six Sigma methodologies for analytical problem solving is preferred.