Manufacturing Engineer III - Katalyst Healthcares & Life Sciences

• Works within cross-functional project teams including Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve manufacturing processes used to manufacture surgical products for the medical device industry.

• Designs, specifies, develops, and purchases manufacturing tooling, fixtures and equipment.

• Manages the implementation and validation of new or modified manufacturing processes and equipment to support the manufacture of Integra products.

• Support and guide transfers internally within plant and externally with suppliers.

• Supports the selection and validation of replacement materials, such as polymers, metals, and adhesives used in the manufacturing of Integra products.

• Writes and implements Manufacturing Procedures and Work Instructions.

• Creates, updates and maintains BOMs, Routers, and DMRs.

• Works as a recognized manufacturing and process technical expert who can provide process engineering knowledge and oversight to resolving manufacturing-related problems with existing products and processes.

• Champions improvement processes for rework, scrap, and labor variance reduction / elimination in the plant processes.

• Supports Material Review Board process by investigating and resolving manufacturing and supplier quality concerns.

• Identifies and provides innovative new manufacturing technologies from industry best practices that can be applied to lntegra products and mfg processes.

• Represents the Manufacturing Engineering group on strategic projects in Manufacturing and Sourcing.

Requirements:

• Bachelor's degree in mechanical, Manufacturing, Materials or Biomedical Engineering or equivalent is required.

• A minimum of 6 years of engineering industry experience is required.

• Experience in the medical device industry is required.

• Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PO qualifications as related to medical devices is required.

• Working knowledge in manufacturing processes such as metal processing (machining, polishing, welding), plastics processing, and mechanical assembly is required.

• Working knowledge of machine and tool design, equipment design, and the startup of new equipment is preferred.

• Experience working in a cleanroom environment is preferred.

• Six Sigma Statistical Process Analysis knowledge is required with certification preferred.

• Mentor and assist Blackbelts/Greenbelts on projects as needed. Assist with tools and Mintab software.

• Knowledge of how to troubleshoot and analyze the effectiveness of manufacturing processes is required. Experience in implementing actions to improve equipment uptime, yield, efficiencies, and quality of production is required.

• Experience in Lean Mfg. and Continuous Improvement Methods is preferred.

• Knowledge of financial accounting and analysis methods to assess product standard costs, project values, product cost improvements and capital purchases is required.

• Strong communication, team building, and cross-functional coordination skills are required.

• Experience with Agile and Oracle data systems is preferred.

• The position is located in Mansfield, MA and requires onsite presence 40 hrs in a week.

• Ability to travel up to 10% domestically is required.