Senior Package Development Engineer (Orthopedics)

Johnson & Johnson Innovative MedicineWest Chester, PA
Onsite

About The Position

Johnson & Johnson is searching for the best talent for a Senior Package Development Engineer (Orthopedics - Trauma) to be located in West Chester, PA. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Requirements

  • Bachelor’s degree in engineering or equivalent Technical Degree or equivalent experience required.
  • 4 – 6 years related experience
  • Experience in the packaging industry
  • Experience in packaging qualification or laboratory testing
  • Experience in a regulated environment
  • Demonstrated record of successful project management.
  • Application and interpretation of process DOE’s (mini-tab preferred), GR&R, IQ/OQ/PQ, Fishbone, etc. is required
  • Demonstrated experience working and communicating with internal and external partners, including vendors and suppliers of direct materials and services
  • Team player
  • Advanced problem-solving Skills
  • Creative
  • Self-starter and independent worker
  • Strategic thinker
  • Leadership mentality

Nice To Haves

  • Knowledge of ISO13485, ISO11607, ISTA and ASTM is preferred

Responsibilities

  • Participates in internal and external Audits and provides technical expertise for risk assessments and compliance assurance programs.
  • Ownership of submissions of Packaging Design Documentation to notified bodies.
  • Assures delivery of robust, cost effective, fully compliant packaging solutions that meet current and evolving customer's needs.
  • Has full technical responsibility for interpreting, organizing, executing and coordinating assignments.
  • Leads troubleshooting in the resolution of packaging related issues in manufacturing and the field.
  • Develops recommendations on general packaging guidelines and standards for processes and functional requirements.
  • Oversees issue management with technical responsibility to ensure problems are solved in a compliant and effective manner and ensure our organization reaches high levels of efficiency.
  • Maintains up to date knowledge of the industry and regulatory trends and standards related to packaging and ensures these are translated into working practices.
  • Knows and follows all laws and policies that apply to one's job, and maintains the highest levels of professionalism, ethics and compliance at all times.
  • Subject matter expert for packaging department (job function dependent) and is responsible for internal and external audits.
  • Serve as a mentor for other team members and may supervise direct reports.
  • Internal cross functional networking and external benchmarking of new technologies, materials, solutions and suppliers.
  • Evaluates the validation approach and strategy to ensure continuous improvement consistent with established and evolving regulatory and company requirements.
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