Sr. Manufacturing Engineer

The Senior Manufacturing Engineer serves as the technical process owner responsible for manufacturing process validations, performance, equipment readiness, capacity expansion, and continuous improvement activities to meet the yield, capacity, throughput, reliability, and quality goals. This role drives the development, validation, implementation, and optimization of manufacturing processes to ensure product quality, regulatory compliance, operational excellence, and successful commercialization. This role partners closely with internal and external stakeholder teams to support production objectives, resolve technical challenges, and execute strategic initiatives that improve manufacturing capability, efficiency, and reliability.
Roles and Responsibilities:

• Designs manufacturing processes, procedures and production layouts for semi automation equipment installation, processing, and material handling.
• Adapts machine or equipment design to factory and production conditions, incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops and maintains manufacturing process specifications, work instructions, and engineering documentation
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Develop and execute equipment and process validation activities, including IQ, OQ, and PQ protocols and test method development and validation
• Supports automation initiatives and advanced manufacturing technologies
• Serve as the primary technical escalation point for complex manufacturing and quality issues.
• Lead root cause investigations utilizing structured problem-solving tools such as 5 Why, Fishbone Analysis, and Statistical Analysis.
• Lead initiatives to improve yield, reduce scrap, increase throughput, and optimize labor utilization.
• Partner with equipment suppliers and internal stakeholders to improve equipment capability and reliability.
• Develop manufacturing strategies for commercial production ramp-up, identify and eliminate bottlenecks impacting manufacturing performance.
• Ensures processes and procedures follow FDA Quality System Regulations, ISO 13485 requirements, and company procedures.

Education and Experience:

• May have practical knowledge of project management.
• Requires a Baccalaureate degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• Experience supporting medical device manufacturing operations, ideally with automated and semi-automated equipment.
• Strong understanding of manufacturing process validation and equipment qualification.
• Experience with statistical analysis and process control methodologies.
• Able to travel ~50%.
• Experience with some mix of Microsoft Office, SAP, MES, AutoCAD, SolidWorks, Minitab, Document Management System.

Required Skills:

• Experience with medical device manufacturing line implementation and validation, ideally with automated and semi-automated equipment.
• Experience with process improvement methodologies, such as Lean/Six Sigma.
• Experience designing and optimizing manufacturing processes, equipment, layouts, material handling, and production workflows.
• Experience with assessment of NCRs/quality issues using problem solving tools (i.e., 5 Why, Fishbone Analysis, and Statistical Analysis) and RCA.