R&D Packaging Engineer 2

Overview

The Packaging Engineer 2 uses their experienced in medical device packaging to design and develop solutions for new and modified products. This includes supporting product design, verification testing, regulatory compliance, process validation and manufacturing line establishment. A Packaging Engineer 2 leads packaging activities with a cross-functional team including SBU Product Management, Regulatory Affairs, Operations, Quality Assurance, Clinical Affairs, and other Engineering personnel.

Responsibilities

• Apply packaging design principles from the Medical Device/Pharma field to develop packaging designs that meet company, customer and industry standards.
• Works with suppliers to spec and acquire packaging materials.
• Coordinate distribution simulation and packaging testing.
• Develop and maintain department standards in packaging.
• Ability to lead multiple projects to successful completion with tight time lines and critical deliverables.
• Ensure compliance of equipment and packaging designs with company quality system.
• Coordinate or perform verification and validation testing of packaging designs and manufacturing methods.
• Write and maintain appropriate documentation per the company quality system.
• Evaluate issues with existing packaging and implement corrective actions.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

Qualifications

Qualification/ Educational Requirements:

• Bachelor's degree in Mechanical Engineering, Packaging Science or closely related field and 3 years experience; or experience of such kind and amount as to provide a comparable background
• Experience with medical packaging materials (Tyvek, PE/PET films, PETG trays, etc.)
• Experience with environmental and regulatory requirements and standards that relate to medical packaging design and testing (i.e. ASTM F1886, F88, F2096, D4169, and ISO 11607)

Physical Requirements:

• Works under general office environmental conditions.
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Researches and designs using standard computer equipment.
• The employee is frequently required to stand; walk; use hands to grasp, feel or touch; reach with hands and arms; climb or balance; stoop; kneel; crouch; or crawl; and talk; or hear.
• Moderate exposure to noise level in the work environment that is moderate to occasionally loud.
• Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.