Senior Project Engineer - Integra LifeSciences
Anasco, PR
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.
This position is responsible for managing and executing projects and/or programs of moderate to high level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs. Ensures that all operational deliverables of the project/program are achieved on or ahead of schedule and within cost standards such that they meet the desired quality, standard, value, business deliverables and or key decision milestones. Responsible for all project elements such as: planning, organization, budgeting, scheduling, execution, tracking, reporting, among others.
Provides project management guidance and business tools, utilizing a systematic approach to project execution. Prepare management reports and presentations. Effective project planning and structure. Generate change controls related to each engineering project, assuring that these are carried out timely, efficiently and in compliance with plant procedures and regulatory agencies. Generate and execute validation protocols, including test reports and evaluation of quality issues and/or deviations reported during validation protocol execution. Reports project status and progress periodically.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Uses Project Management and Lean/Six Sigma tools to manage major engineering projects, assuring that time, cost and quality requirements are met.
Leads, develops and manages all project scheduling, resource forecasting, and project controls for the delivery of the project within the desired parameters of time, cost and quality.
Performs cost analyses and inventory projections as a result of engineering projects. Prepares cost and time estimates for engineering and project schedules.
Proactively identifies and manages emerging changes and opportunities and drives iterations of the plans including updates in the project schedule.
Develops, coordinates, and implements the change controls related to each engineering project. Evaluates and assures completeness of change control requirements for projects under responsibility.
Writes engineering test protocols for testing of component parts and integrated systems.
Develops and/or executes validations of revised/new raw materials, products, processes and/or equipment, following Integra procedures as a result of engineering projects.
Develops the required documentation, procedures, drawings, protocols, engineering change orders, technical reports and other information as required by the company.
Development of process controls for new and existing equipment and/or processes.
Develop and implement Six Sigma/Lean projects and quality improvement plans. Identify and implement opportunities for continuous improvement.
Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.
Performs other related duties as necessary.
Knowledge, skills, and abilities:
+ Knowledge in Organizational Excellence and Lean/Six Sigma.
+ Strong Project Management skills and knowledge in Microsoft Project software.
+ Ability to lead teams through complex projects and provide departmental technical leadership.
+ Must have excellent communication skills and a strong track record of working cross-functionally.
+ Ability to effectively solve complex problems and ability to influence and communicate across all functional groups and levels.
+ Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Minimum Qualifications:
+ BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
+ Master’s degree is a plus.
+ PE License strongly desired.
+ Lean/Six Sigma Green or Black Belt Certification is a plus.
+ Project Management Professional (PMP) certification strongly desired.
+ Experience in New Product transfer into Manufacturing (Design Transfer) and Design Controls required.
+ Minimum of 5 – 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in an engineering project management position and preferably with exposure to Design Control and Product/Process Transfer as well as with a successful track record in project management.
+ Fully bilingual (English and Spanish).
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.
This position is responsible for managing and executing projects and/or programs of moderate to high level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs. Ensures that all operational deliverables of the project/program are achieved on or ahead of schedule and within cost standards such that they meet the desired quality, standard, value, business deliverables and or key decision milestones. Responsible for all project elements such as: planning, organization, budgeting, scheduling, execution, tracking, reporting, among others.
Provides project management guidance and business tools, utilizing a systematic approach to project execution. Prepare management reports and presentations. Effective project planning and structure. Generate change controls related to each engineering project, assuring that these are carried out timely, efficiently and in compliance with plant procedures and regulatory agencies. Generate and execute validation protocols, including test reports and evaluation of quality issues and/or deviations reported during validation protocol execution. Reports project status and progress periodically.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Uses Project Management and Lean/Six Sigma tools to manage major engineering projects, assuring that time, cost and quality requirements are met.
Leads, develops and manages all project scheduling, resource forecasting, and project controls for the delivery of the project within the desired parameters of time, cost and quality.
Performs cost analyses and inventory projections as a result of engineering projects. Prepares cost and time estimates for engineering and project schedules.
Proactively identifies and manages emerging changes and opportunities and drives iterations of the plans including updates in the project schedule.
Develops, coordinates, and implements the change controls related to each engineering project. Evaluates and assures completeness of change control requirements for projects under responsibility.
Writes engineering test protocols for testing of component parts and integrated systems.
Develops and/or executes validations of revised/new raw materials, products, processes and/or equipment, following Integra procedures as a result of engineering projects.
Develops the required documentation, procedures, drawings, protocols, engineering change orders, technical reports and other information as required by the company.
Development of process controls for new and existing equipment and/or processes.
Develop and implement Six Sigma/Lean projects and quality improvement plans. Identify and implement opportunities for continuous improvement.
Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.
Performs other related duties as necessary.
Knowledge, skills, and abilities:
+ Knowledge in Organizational Excellence and Lean/Six Sigma.
+ Strong Project Management skills and knowledge in Microsoft Project software.
+ Ability to lead teams through complex projects and provide departmental technical leadership.
+ Must have excellent communication skills and a strong track record of working cross-functionally.
+ Ability to effectively solve complex problems and ability to influence and communicate across all functional groups and levels.
+ Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Minimum Qualifications:
+ BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
+ Master’s degree is a plus.
+ PE License strongly desired.
+ Lean/Six Sigma Green or Black Belt Certification is a plus.
+ Project Management Professional (PMP) certification strongly desired.
+ Experience in New Product transfer into Manufacturing (Design Transfer) and Design Controls required.
+ Minimum of 5 – 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in an engineering project management position and preferably with exposure to Design Control and Product/Process Transfer as well as with a successful track record in project management.
+ Fully bilingual (English and Spanish).
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
