Manufacturing Engineer III

Description

on-site role

M-F business hours

Would be looking for ME’s that have done IQ, OQ, PQ’s, strong Solidworks skills and knowledge of Medical Device regulations and cleanroom practices is desired.

Essential Duties And Responsibilities

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

Primary responsibilities are to:

• 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 lntegra 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 lntegra 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.
  
  

Desired Minimum Qualifications

• 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 on how to troubleshoot and analyze 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.
• Position is located in Mansfield, MA and requires onsite presence 40 hrs week.
• Ability to travel up to 10% domestically is required