Senior Manufacturing Engineer - Integra LifeSciences
Mansfield, MA
About the Job
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
+ 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.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
+ 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.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences
