Senior Process Engineer - North Haven, CT
$103,200–$154,800 year
On-siteNorth Haven, Connecticut, United States
Job Summary
Support day-to-day manufacturing of absorbable and non-absorbable sutures, including polymer development, crystallization, purification, extrusion, annealing, and textile processes. Lead cross-functional teams to plan, track, and deliver technical, operational, and financial objectives while driving continuous improvement initiatives. Provide technical expertise for equipment specification, procurement, installation, qualification, validation, troubleshooting, and training across chemical, polymer extrusion, and biomedical manufacturing. Identify opportunities to improve process capability and efficiency through data analysis and statistical methods. Execute engineering qualifications and process validations, including IQ/OQ/PQ activities, and partner with Manufacturing, Quality, and Maintenance teams to investigate production issues and implement corrective actions. Manage engineering change notices, BOM creation, and ERP system activities.
Required Qualifications
- Bachelor's degree with a minimum of 4 years of relevant experience
- Master's degree with a minimum of 2 years relevant experience
- PhD with 0 years relevant experience
- Experience applying statistical methods and science-based decision making to design experiments and implement process improvements
- Experience managing multiple projects and priorities in a manufacturing, engineering, or product development environment
- Experience working on cross-functional teams to deliver technical projects and business objectives
- Experience using Minitab for data analysis and problem solving
Desired Qualifications
- Experience in the medical device industry
- Experience with Design for Reliability (DFR), Design for Six Sigma (DFSS), and/or Lean Six Sigma methodologies
- Experience supporting absorbable polymer products or technologies
- Experience with polymer development and manufacturing, fiber extrusion, textile manufacturing, and/or material characterization
- Lean Six Sigma Green Belt or Black Belt certification
- Bachelor's degree or an advanced degree in Chemistry, Chemical, Mechanical, Bio-Medical Engineering, or related
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