Senior Process Engineer

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: RequiredBachelor'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. PreferredExperience 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.