Manufacturing Engineer III

Job Title: Manufacturing Engineer III
Location: Mansfield, MA 02048
Duration: 6 Months+ – Possibility of Extension
 
Pay range: $55 - $61/hr. on W2
 
Description:
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 company 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 company 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 with the best practices that can be applied to Company 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’ experience of engineering industry 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