Johnson & Johnson Vison (JJV) is recruiting for a Director, Package Engineering & Product Labeling, located in Santa Ana, CA
JJV, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the JJV brand and fortifying our position as the worldwide leader in total eye healthcare solutions.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The leader is accountable to a meaningful role in the organization for leading, designing and driving the implementation of an end-to-end strategy and aspirations that enable company growth and achieve business objectives in the functional area of Package Engineering and Product Labeling. The role is responsible for groundbreaking leadership and the execution of all global Labeling/Packaging strategies, including negotiations with internal and external parties with accountability for meeting agreed upon scope, cost, schedule, quality measures, and updating partners, senior management, and other team members with project status, issue resolution and executive briefings while establishing a motivating and trusting environment where all team members can experience professional growth and a sense of self-worth and value to the organization.
- Responsible for ensuring functional processes and systems (from design, development and deployment encompassing component suppliers, assembly processes, sealing processes, distribution channels and packaging postponement processes) are harmonized, maintained, and consistently delivering outputs across all assigned business units
- Responsible for continuous improvement and driving consistency in functional design inputs, execution steps, and output delivery.
- Responsible for 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 leadership to provide solutions for key functional groups (eg. Regulatory Affairs, Legal, Quality, Compliance, Supply Chain, and R&D).
- Ensure all global regulations are anticipated, understood, and followed on a timely basis in the functional area of responsibility.
- Developing talent and supporting capability enhancement and capability building strategies.
- Driving technical expertise and proficiency in application of Process Excellence methodologies in support of team deliverables.
- Driving technical expertise and proficiency in Project Management and Program Management principles in support of team deliverables.
- Provide leadership to establish project management and program management processes as appropriate for the scope of deliverables, which may include program metrics, tools and templates, tracking mechanisms such as scorecards or dashboards, and program governance.
- 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 New Product Introduction (NPI/NPD) and Life Cycle Management processes.
- Other responsibilities not listed may be assigned & not all responsibilities listed may be assigned.
- B.A./B.S. in engineering or scientific field required; B.S. in Package Engineering preferred; Advanced Engineering degree or MBA preferred
- 12+ years of experience in process/product engineering with resource management supporting manufacturing functions, design and development and handling multiple projects and business objectives simultaneously while leading cross functional project teams.
- Minimum of 5 years of managerial experience
- 2+ years of Supply Chain or Manufacturing experience preferred
- Six Sigma or Lean Black Belt preferred
- Project Management Professional (PMP) preferred
- 2 plus years of experience in Labeling and/or Packaging within the Medical Device Industry is required
- Demonstrated ISO 13485, ISO 15223, ISO 11607, ISO 16775 knowledge and experience required.
- Demonstrated knowledge of appropriate test methods for sterile barrier packaging systems, specifically, ASTM D10 and ASTM F02 methods.
- Knowledge and experience with Human Factors and Usability testing for labeling content and aseptic transfer techniques.
- Experience with FDA and/or notified body audits in the functional space of packaging and/or labeling.
- Demonstrated results in Quality Control, Compliance, Sterility Assurance and Regulatory for medical devices
- Demonstrated strong business acumen and financial management ensuring budget attainment.
- Demonstrated Critical thinking, planning & big picture orientation
- Influence Management and Change Management experience
- Ability to set strategic direction for organization and broadly communicate the vision.
- Confirmed ability to engage and run multiple projects including multinational engineering teams.
- Shown ability to consistently generate and implement innovative and unique solutions to complex technical problems is required
- A track record of successfully maintaining and mentoring highly educated, skilled engineers in an ambitious environment and verifiable achievements wherein creativity and innovation have been confirmed.
- Customer focus (internal & external) and a strong eye for business skills are desired.
- Results Driven and a Sense of Urgency
- Manufacturing process & Supplier Management knowledge and experience for medical devices.
- Requires the ability to travel up to 35%, both domestically and internationally, is required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-California-Santa Ana-Organization
Johnson & Johnson Surgical Vision, Inc (6234)Job Function