Johnson & Johnson companies are equal opportunity employers.
MANAGER PACKAGE DEVELOPMENT-9520140716
Description
Ethicon Surgical Care is currently recruiting for Manager for their packaging development team in their Somerville, New Jersey location.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Package Development Leader is managing a team of packaging engineers, assuring development of packaging to support new product development teams.
Support and execute Research and Development priorities with impact assessments and configuration management impacting package design, packaging materials and design control documentation.
Providing leadership in processes for package design
Ensuring Package Development processes and systems (from design, development and deployment encompassing component suppliers, assembly processes, sealing processes, distribution channels and package postponement processes) are harmonized, maintained, and consistently delivering outputs across all of the Global Surgery franchises.
Driving consistency in Package Development platform designs, testing requirements, material selection, specification development,, execution steps, and output delivery
Driving consistent and robust corrective actions to resolve CAPAs, non-conformances, and audit findings while enabling knowledge sharing across the community of practice for package design, package process, label design and label process.
Supporting the Center of Excellence leadership to provide solutions for key functional groups ( Regulatory Affairs, Legal, Quality, Compliance, Supply Chain, and R&D) Ensuring all global regulations are anticipated, understood, and complied with on a timely basis across Global Surgery’s Package Development CoE.
Developing talent within the Package Development CoE teams and supporting capability enhancement and capability building strategies.
Know & follow Global Surgery policies & procedures & assure that direct reports know them.
Complete training in area of responsibility & assure that direct reports are trained within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures. Complete required periodic re-training & assure that required periodic re-training takes place for direct reports in areas such as safety & environmental. Set standards for safe behavior.
Identify and mitigate Package Development process risks. Drive quality output from each process from supplier and design inputs, through execution, and output.
Ensure responses to quality system findings (CAPA, nonconformance, audits) are consistent, robust, appropriate for Global Surgery, and timely.
Partner with Regulatory Affairs, Compliance, Stability, Sterility and Packaging/Labeling PMOs to ensure all global regulations are anticipated, understood, and complied with on a timely basis for Global Surgery’s Package Development.
Develop talent within the Package Development CoE teams, and ensuring quality and compliance skills are continuously increasing.
Understand Critical Control Point methodology and CCPs in the Package Development CoE
Act as strong advocate for Quality/Compliance and support Quality processes
Ensure sufficient resources are available to meet business objectives
Consistently execute projects using proven leadership in Process Excellence and Project Management
Provide leadership to use project management processes as appropriate for the successful execution of projects.
Provide leadership to develop and improve project management expertise among staff associates across the Package Development CoE.
Provide leadership to develop and improve Process Excellence expertise among staff associates across the Package Development CoE
Maintain project prioritization and communications to Package Development CoE and GSG Leadership.
Ensure deliverables comply with company and external standard
Provide leadership in: Continuous improvement projects. Quality System responses
Supplier partnerships and output control, and risk reduction programs. Distribution and postponement controls. Development/monitoring of package design control systems to support the R&D & FOD processes.
Other responsibilities may be assigned & not all responsibilities listed may be assigned
Qualifications
A Bachelor’s of Science Degree in engineering or technical field with a minimum of 9 year’s experience in Package Development is required for this role.
B.S. in Package Engineering preferred. An advanced degree is also preferred.
Medical Device and/or Pharmaceutical industry experience is required. Combination products experience is an asset.
Demonstrated people development skills and technical leadership is required. Organization & Talent management is preferred.
Formal training or demonstrated experience in sterile barrier packaging system/ design verification preferred. Understanding of Sterilization modes used in medical devices preferred.
Professional certification - Six Sigma/Process Excellence preferred
Professional certification – Project Management Professional preferred
Knowledge and experience with ISO 13485, ISO 15223 are preferred. ISO 11607 knowledge and experience is required for this role.
Understanding of Package Development design/development is required. Regulations and Standards for packaging is required. New Product Development processes are required.
Packaging change Control processes is required. Package Assembly and Manufacturing processes is required. Understanding of Supply Chain network and Distribution channels is required. Sterilization knowledge and experience is preferred. Familiar with ASTM for test methods for Sterile Barrier integrity is preferred.
Demonstrated results in Quality Control, Compliance, and Regulatory is preferred.
Strong Business Acumen skills are important in this role to include. Strategic thinking & big picture orientation, Influence Management and Budget planning/fiscal responsibility are all preferred.
Project management skills are preferred. Program management skills are preferred
Strong written & verbal communication skills. Customer focus with business partnering (internal & external) are preferred. Results Driven and a Sense of Urgency
This position could require up to 25% travel both domestic and international.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)
Job Function: Packaging
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
MANAGER PACKAGE DEVELOPMENT-9520140716
Description
Ethicon Surgical Care is currently recruiting for Manager for their packaging development team in their Somerville, New Jersey location.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Package Development Leader is managing a team of packaging engineers, assuring development of packaging to support new product development teams.
Support and execute Research and Development priorities with impact assessments and configuration management impacting package design, packaging materials and design control documentation.
Providing leadership in processes for package design
Ensuring Package Development processes and systems (from design, development and deployment encompassing component suppliers, assembly processes, sealing processes, distribution channels and package postponement processes) are harmonized, maintained, and consistently delivering outputs across all of the Global Surgery franchises.
Driving consistency in Package Development platform designs, testing requirements, material selection, specification development,, execution steps, and output delivery
Driving consistent and robust corrective actions to resolve CAPAs, non-conformances, and audit findings while enabling knowledge sharing across the community of practice for package design, package process, label design and label process.
Supporting the Center of Excellence leadership to provide solutions for key functional groups ( Regulatory Affairs, Legal, Quality, Compliance, Supply Chain, and R&D) Ensuring all global regulations are anticipated, understood, and complied with on a timely basis across Global Surgery’s Package Development CoE.
Developing talent within the Package Development CoE teams and supporting capability enhancement and capability building strategies.
Know & follow Global Surgery policies & procedures & assure that direct reports know them.
Complete training in area of responsibility & assure that direct reports are trained within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures. Complete required periodic re-training & assure that required periodic re-training takes place for direct reports in areas such as safety & environmental. Set standards for safe behavior.
Identify and mitigate Package Development process risks. Drive quality output from each process from supplier and design inputs, through execution, and output.
Ensure responses to quality system findings (CAPA, nonconformance, audits) are consistent, robust, appropriate for Global Surgery, and timely.
Partner with Regulatory Affairs, Compliance, Stability, Sterility and Packaging/Labeling PMOs to ensure all global regulations are anticipated, understood, and complied with on a timely basis for Global Surgery’s Package Development.
Develop talent within the Package Development CoE teams, and ensuring quality and compliance skills are continuously increasing.
Understand Critical Control Point methodology and CCPs in the Package Development CoE
Act as strong advocate for Quality/Compliance and support Quality processes
Ensure sufficient resources are available to meet business objectives
Consistently execute projects using proven leadership in Process Excellence and Project Management
Provide leadership to use project management processes as appropriate for the successful execution of projects.
Provide leadership to develop and improve project management expertise among staff associates across the Package Development CoE.
Provide leadership to develop and improve Process Excellence expertise among staff associates across the Package Development CoE
Maintain project prioritization and communications to Package Development CoE and GSG Leadership.
Ensure deliverables comply with company and external standard
Provide leadership in: Continuous improvement projects. Quality System responses
Supplier partnerships and output control, and risk reduction programs. Distribution and postponement controls. Development/monitoring of package design control systems to support the R&D & FOD processes.
Other responsibilities may be assigned & not all responsibilities listed may be assigned
Qualifications
A Bachelor’s of Science Degree in engineering or technical field with a minimum of 9 year’s experience in Package Development is required for this role.
B.S. in Package Engineering preferred. An advanced degree is also preferred.
Medical Device and/or Pharmaceutical industry experience is required. Combination products experience is an asset.
Demonstrated people development skills and technical leadership is required. Organization & Talent management is preferred.
Formal training or demonstrated experience in sterile barrier packaging system/ design verification preferred. Understanding of Sterilization modes used in medical devices preferred.
Professional certification - Six Sigma/Process Excellence preferred
Professional certification – Project Management Professional preferred
Knowledge and experience with ISO 13485, ISO 15223 are preferred. ISO 11607 knowledge and experience is required for this role.
Understanding of Package Development design/development is required. Regulations and Standards for packaging is required. New Product Development processes are required.
Packaging change Control processes is required. Package Assembly and Manufacturing processes is required. Understanding of Supply Chain network and Distribution channels is required. Sterilization knowledge and experience is preferred. Familiar with ASTM for test methods for Sterile Barrier integrity is preferred.
Demonstrated results in Quality Control, Compliance, and Regulatory is preferred.
Strong Business Acumen skills are important in this role to include. Strategic thinking & big picture orientation, Influence Management and Budget planning/fiscal responsibility are all preferred.
Project management skills are preferred. Program management skills are preferred
Strong written & verbal communication skills. Customer focus with business partnering (internal & external) are preferred. Results Driven and a Sense of Urgency
This position could require up to 25% travel both domestic and international.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI
Primary Location:North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)
Job Function: Packaging
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement