Chief Executive Officer
Limiting Uncertainty For The Busiest Surgeons
Senior Manufacturing EngineerMansfield, MA
The Senior Manufacturing Engineer will work 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
– Manages the implementation and validation of new or modified manufacturing processes and equipment to support the manufacture of lntegra
– Support and guide transfers internally within plant and externally with
– 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
– 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
– Champions improvement processes for rework, scrap, and labor variance reduction / elimination in the plant
– Supports Material Review Board process by investigating and resolving manufacturing and supplier quality
– Identifies and provides innovative new manufacturing technologies from industry best practices that can be applied to lntegra products and mfg
– Represents the Manufacturing Engineering group on strategic projects in Manufacturing and Sourcing.
– Bachelor’s degree in Mechanical, Manufacturing, Materials or Biomedical Engineering or equivalent.
– A minimum of 6 years of engineering industry experience.
– Experience in the medical device industry.
– Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PO qualifications as related to medical devices.
– Working knowledge in manufacturing processes such as metal processing (machining, polishing, welding), plastics processing, and mechanical assembly.
– Working knowledge of machine and tool design, equipment design, and the startup of new equipment.
– Experience working in a cleanroom environment.
– Six Sigma Statistical Process Analysis knowledge is required with certification.
– Mentor and assist Blackbelts/Greenbelts on projects as 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.
– Experience in Lean Mfg and Continuous Improvement Methods.
– Knowledge of financial accounting and analysis methods to assess product standard costs, project values, product cost improvements and capital purchases.
– Strong communication, team building, and cross-functional coordination skills .
– Experience with Agile and Oracle data systems.
Position is located in Mansfield, MA and requires onsite presence 40 hrs.
Ability to travel up to 10% domestically is required.