Integra LifeSciences

Overview

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.

Responsibilities

-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.

Qualifications

– 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.