Sr. Manufacturing/Process Engineer

Duties and Responsibilities

• Lead the development, validation, and continuous improvement of manufacturing and process technologies for medical device products in accordance with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
• Serve as a senior technical resource for manufacturing and process engineering activities across multiple product lines.
• Lead complex, cross-functional projects from concept through commercialization, including new product introductions, line extensions, and transfers from R&D to manufacturing.
• Develop, qualify, and validate new manufacturing processes and equipment, including authorship and execution of IQ/OQ/PQ protocols, test method validations (TMV), and process validation reports.
• Create and maintain the process validation master plan.
• Apply statistical methods including Design of Experiments (DOE), Statistical Process Control (SPC), Measurement System Analysis (MSA/Gage R&R), and process capability analysis to develop, characterize, troubleshoot, and control manufacturing processes.
• Lead risk management activities for manufacturing processes, including authorship and review of PFMEAs.
• Drive Design for Manufacturability (DFM) input during product development and design transfer activities.
• Identify, evaluate, and implement opportunities to reduce cycle time, scrap, and manufacturing cost; develop and execute plans to capitalize on these opportunities.
• Apply Lean manufacturing principles and continuous improvement methodologies to optimize production workflows, layouts, and equipment utilization.
• Lead the evaluation, specification, design, and qualification of tools, fixtures, custom equipment, and production systems to meet capability and capacity requirements.
• Monitor process output, yield, and scrap; analyze trends and drive corrective actions to improve performance.
• Perform and oversee cleanroom (Class 8) validations as required.
• Manage activities with outside vendors and contract manufacturers providing components, assemblies, processes, testing, and other services.
• Lead investigations of nonconformances and support CAPA activities, including root cause analysis and effectiveness checks.
• Author, review, and approve standard operating procedures, work instructions, engineering change orders, and related quality system documentation.