Senior Process Engineer - North Haven, CT
Core
Senior Process Engineer leading cross-functional teams to drive manufacturing performance, process improvements, and new product transitions for surgical sutures and biomedical devices.
Role type
Senior hands-on IC process engineer
Builds
Production equipment and manufacturing processes for absorbable/non-absorbable sutures
Domain
Medical device manufacturing (chemical, extrusion, textile)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
statistical methods, design of experiments, project management, cross-functional collaboration, Minitab, engineering qualifications, root cause analysis, BOM management, ERP/SPAC systems
Preferred skills
Design for Reliability (DFR), Design for Six Sigma (DFSS), Lean Six Sigma, polymer development, fiber extrusion, textile manufacturing, material characterization
Technologies
Minitab, ERP/SPAC systems
Responsibilities
Support day-to-day manufacturing of sutures including polymer development, crystallization, purification, extrusion, annealing, and textile processes; Lead cross-functional teams to plan and deliver technical, operational, and financial objectives; Provide technical expertise for specification, procurement, installation, qualification, validation, troubleshooting, and training of manufacturing equipment; Identify and lead opportunities to improve process and equipment capability, reliability, and efficiency through data analysis and continuous improvement; Support new product development, quality improvement, and capital equipment projects; Execute engineering qualifications and process validations (IQ/OQ/PQ); Partner with cross-functional teams to investigate production issues, perform root cause analysis, and implement corrective actions; Manage engineering change notices, BOM creation, and provide mentorship to junior staff
Seniority
Senior, hands-on IC
