Senior Project Engineer, LCM Operations - Integra LifeSciences
Anasco, PR
About the Job
Changing lives. Building Careers.
Joining us is a chance 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, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Sr Engineer, Life Cycle Management (LCM) will work within the Integra Lifesciences CSS Engineering organization to support the design changes impacting operations, manufacturing, launch readiness and production stability requirements of existing products. This position will provide technical expertise and project management in the areas of medical device life cycle management, supplier change management, COGs, process development, validation and production stability.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Lead and Participate on cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve surgical products.
+ Responsible for reviewing and updating applicable product specifications and drawings for legacy products. Responsible for identifying acceptance criteria for product specifications.
+ Develop project plans for qualifications and ensure team resources identified, team members help accountable to deliverables, and milestones met.
+ Provide engineering knowledge and oversight to resolve design, manufacturing, and quality-related problems impacting existing products.
+ Proactively manages priorities based on changing needs; adjusts priorities to minimize impact to other business needs; communicates priorities as appropriate.
+ Support and lead manufacturing process improvements for CSS products in both internal manufacturing facilities and in partnership with external suppliers.
+ Provide project leadership to improve existing products and associated manufacturing processes.
+ Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, for CSS applications.
+ Represent the Lifecycle Engineering group on strategic projects in impacting operations and Sourcing.
+ Responsible for managing corrective actions and the implementation of all corrective actions to ensure improvements are attained.
DESIRED MINIMUM QUALIFICATIONS:
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education:
+ Minimum of a bachelor's degree in mechanical, manufacturing, materials or biomedical engineering or equivalent is required. Master's degree preferred.
Experience:
+ 5+ years of experience with B.S. or Master's degree with 3+ years of experience, Doctoral degree with 0-2 years of experience
+ PMP Certification preferred.
+ Medical device industry experience is preferred.
+ Knowledge of how to execute GMPs, ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices is required.
+ Knowledge of Six Sigma Process Excellence is preferred.
+ Knowledge in manufacturing processes such as polymer processing (molding, compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing, welding), assembly, equipment & tool design is required.
+ Knowledge of Design for Manufacturability in plastics, metals and small-scale assembly processes is preferred.
+ Knowledge of financial accounting and analysis methods to assess product standard costs, project values, cost improvements and capital purchases is preferred.
+ Leadership experience in managing technical relationships with external suppliers and OEMs is required.
+ Strong communication, team building, and cross-functional coordination skills are required.
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 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, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Sr Engineer, Life Cycle Management (LCM) will work within the Integra Lifesciences CSS Engineering organization to support the design changes impacting operations, manufacturing, launch readiness and production stability requirements of existing products. This position will provide technical expertise and project management in the areas of medical device life cycle management, supplier change management, COGs, process development, validation and production stability.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
+ Lead and Participate on cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to maintain and improve surgical products.
+ Responsible for reviewing and updating applicable product specifications and drawings for legacy products. Responsible for identifying acceptance criteria for product specifications.
+ Develop project plans for qualifications and ensure team resources identified, team members help accountable to deliverables, and milestones met.
+ Provide engineering knowledge and oversight to resolve design, manufacturing, and quality-related problems impacting existing products.
+ Proactively manages priorities based on changing needs; adjusts priorities to minimize impact to other business needs; communicates priorities as appropriate.
+ Support and lead manufacturing process improvements for CSS products in both internal manufacturing facilities and in partnership with external suppliers.
+ Provide project leadership to improve existing products and associated manufacturing processes.
+ Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, for CSS applications.
+ Represent the Lifecycle Engineering group on strategic projects in impacting operations and Sourcing.
+ Responsible for managing corrective actions and the implementation of all corrective actions to ensure improvements are attained.
DESIRED MINIMUM QUALIFICATIONS:
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Education:
+ Minimum of a bachelor's degree in mechanical, manufacturing, materials or biomedical engineering or equivalent is required. Master's degree preferred.
Experience:
+ 5+ years of experience with B.S. or Master's degree with 3+ years of experience, Doctoral degree with 0-2 years of experience
+ PMP Certification preferred.
+ Medical device industry experience is preferred.
+ Knowledge of how to execute GMPs, ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices is required.
+ Knowledge of Six Sigma Process Excellence is preferred.
+ Knowledge in manufacturing processes such as polymer processing (molding, compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing, welding), assembly, equipment & tool design is required.
+ Knowledge of Design for Manufacturability in plastics, metals and small-scale assembly processes is preferred.
+ Knowledge of financial accounting and analysis methods to assess product standard costs, project values, cost improvements and capital purchases is preferred.
+ Leadership experience in managing technical relationships with external suppliers and OEMs is required.
+ Strong communication, team building, and cross-functional coordination skills are required.
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
