Staff Package Development Engineer – Orthopedics, Trauma

Role Overview

• 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.

Requirements

• Bachelor’s degree in engineering or equivalent Technical Degree or equivalent experience required.
• 6 – 8 years related experience.
• Proven track record in the packaging industry.
• Experience responding to notified bodies and Health Authorities.
• Proven track record in qualification or laboratory testing.
• Experience in regulated industry.
• Experience strategizing and leading projects.
• Knowledge of ISO13485, ISO11607, ISTA and ASTM is preferred.
• Demonstrated experience working and communicating with internal and external partners, including vendors and suppliers of direct materials and services.
• Excellent technical writing skills and understanding required to include and approve protocols, engineering studies, procedures, project status & special reports.
• Experience in engineering activities such as FMEA, CAPA, and NC required.

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year