Mftg. Engineer II

Overview

The Manufacturing Engineer II is responsible for developing, implementing, and improving manufacturing processes, equipment, and methods to increase efficiency, yield, capacity, and product quality. This role provides technical leadership for new and existing manufacturing processes including form-fill-seal packaging, automation implementation, coagulant dipping, and secondary operations, while supporting new product development, process validation, technology transfer, and cost reduction initiatives.

The Manufacturing Engineer II serves as a key contributor on cross-functional teams, leading moderately complex projects, supporting capital investments, and applying Lean and Six Sigma methodologies within a regulated medical device manufacturing environment.

Essential Duties and Responsibilities include the following (Other duties may be assigned):

• Manufacturing Engineering & Process Development:
  Serve as the Manufacturing Engineering representative on product development projects, leading design for manufacturability (DFM), packaging selection, and manufacturing process definition.
• Develop, optimize, and sustain manufacturing processes across form-fill-seal packaging, automation implementation, coagulant dipping, and secondary operations.
• Analyze manufacturing processes to determine feasibility of in-house production versus outsourcing.
• Develop cost estimates and support cost reduction initiatives through process optimization, automation, tooling improvements, and waste elimination.
• Maintain technical ownership of assigned processes and equipment, including troubleshooting, continuous improvement, and performance monitoring.
• Process Optimization & Continuous Improvement:
  Identify and implement continuous improvement opportunities using Lean Manufacturing and Six Sigma tools.
• Apply structured problem-solving methodologies to resolve complex manufacturing and quality issues.
• Optimize process parameters, tooling designs, and equipment utilization to improve capacity, quality, and efficiency.
• Support automation initiatives by evaluating, piloting, and implementing equipment upgrades, robotics, vision systems, and process controls.
• New Product Development & Technology Transfer:
  Collaborate with design, quality, sourcing, and project engineering teams to support successful new product launches.
• Lead or support the development of robust manufacturing processes for new products, including pilot builds and scale-up activities.
• Execute technology transfer activities for new and existing processes to internal manufacturing and qualified external suppliers.
• Validation, Qualification & Quality Systems:
  Coordinate and execute process validations and equipment qualifications (IQ/OQ/PQ) for new and existing manufacturing processes and equipment.
• Generate, update, and maintain quality system documentation including SOPs, work instructions, validation protocols and reports.
• Ensure compliance with ISO 13485, FDA, and other applicable regulatory and quality system requirements.
• Participate in MRB, change control, and continuous improvement activities as a manufacturing engineering stakeholder.
• Capital Equipment & Project Execution:
  Support capital equipment projects by developing business justifications, technical specifications, and vendor requirements.
• Lead or co-lead capital equipment installation, commissioning, and qualification activities for assigned projects.
• Work with suppliers and vendors to ensure proper equipment design, delivery, and integration into production.
• Sourcing & Supplier Support:
  Support the qualification and technology transfer of CIVCO manufacturing processes to external suppliers.
• Collaborate with sourcing and quality teams to define and implement product and process requirements for suppliers.
• Support supplier troubleshooting, process improvements, and ongoing performance monitoring.
• Materials & Manufacturing Technologies:
  Identify and evaluate materials and processing methods including injection molding, cutting, sealing, bonding, punching, die-cutting, assembly, sterile packaging, biocompatibility, and shelf-life considerations.
• Collaborate with Quality Engineering to ensure regulatory compliance of materials and processes.
• Project Leadership & Communication:
  Plan, schedule, and lead department-level and cross-functional projects within defined scope, timeline, and budget.
• Communicate effectively with internal stakeholders regarding manufacturing performance, improvement initiatives, and project status.
• Provide technical guidance to technicians, operators, and tooling resources as needed.
• Personal Development & Technical Growth:
  Maintain working knowledge of new and existing manufacturing technologies, materials, and equipment.
• Participate in relevant training and professional development opportunities.
• Stay current with industry best practices and emerging manufacturing technologies.

To perform this job successfully, an individual must be able to perform each essential duty…