Senior Process Engineer

The Senior Process Engineer will lead the development, validation, optimization, and continuous improvement of manufacturing processes within a regulated medical device environment. This role partners with Engineering, Operations, Quality, R&D, and Supply Chain to improve process capability, yield, efficiency, product quality, and cost. The ideal candidate brings strong technical problem-solving skills, hands-on manufacturing experience, and knowledge of medical device quality requirements.

Key Responsibilities

• Lead process development, optimization, validation, and continuous improvement initiatives.
• Develop and execute process validation activities, including IQ, OQ, and PQ.
• Analyze manufacturing data to improve yield, cycle time, throughput, capability, and cost.
• Lead root-cause investigations, CAPA, nonconformance resolution, and corrective actions.
• Support NPI, design transfer, process transfer, and production scale-up.
• Develop and maintain process specifications, work instructions, validation documentation, and engineering reports.
• Support equipment qualification, tooling, automation, and manufacturing technology improvements.
• Apply Lean, Six Sigma, SPC, DOE, PFMEA, and other process improvement methodologies.
• Partner with Quality and Regulatory teams to maintain compliance with FDA and ISO requirements.
• Lead cross-functional engineering projects and provide technical guidance to manufacturing teams.

Qualifications

Required

• Bachelor's degree in Engineering, Manufacturing, Biomedical Engineering, or a related technical field.
• 5+ years of process or manufacturing engineering experience, preferably in medical devices or regulated manufacturing.
• Experience with process validation, manufacturing process development, and continuous improvement.
• Knowledge of FDA Quality System requirements and ISO 13485.
• Experience with root-cause analysis, CAPA, SPC, DOE, and process capability.
• Experience supporting NPI, design transfer, or manufacturing transfer.
• Strong analytical, communication, project management, and problem-solving skills.
• Proficiency with Microsoft Office.

Preferred

• Experience with medical device manufacturing, automation, or advanced manufacturing technologies.
• Experience with Minitab, JMP, or similar statistical software.
• Knowledge of PFMEA, control plans, DFM/DFA, and risk management.
• Experience with ERP, MES, or manufacturing systems.

What We Offer

• Competitive salary and performance incentives.
• Medical, dental, and vision benefits.
• Employer-sponsored retirement plan.
• Paid time off and company holidays.
• Professional development and career advancement opportunities.
• Collaborative environment focused on quality and continuous improvement.