Senior Package Development Engineer – Orthopedics

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.

• 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.
• Knowledge of ISO
  13485, ISO
  11607, ISTA and ASTM is preferred
• 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