Senior Package Development Engineer (Orthopedics)

Position Duties And 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
• Affirms delivery of robust, cost effective, fully compliant packaging solutions that meet current and evolving customer's needs.
• Owns 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.
• Serves 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.

Education Requirements

• Bachelor’s degree in engineering or equivalent Technical Degree or equivalent experience required.
• Experience 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 ISO13485, ISO11607, 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.

Interpersonal Skills/Characteristics

• Team player
• Advanced problem-solving Skills
• Creative
• Self-starter and independent worker
• Strategic thinker
• Leadership mentality