Medical Packaging Engineer

Description for Medical Packaging Engineer:

The Packaging Engineer supports all packaging-related activities across the company, and works in conjunction with other departments including Operations, Business Development, and Quality Assurance to implement and support new and existing packaging processes.

Responsibilities for Medical Packaging Engineer:

• Develop and execute packaging process validations (IQ/OQ/PQ) and design verification testing.
• Assist Facilities, Operations, and Calibration departments with maintenance and calibration of packaging equipment.
• Investigate manufacturing deviations and assist Quality Assurance with implementing corrective actions (CAPA) related to packaging.
• Lead and provide input to risk assessment activities related to packaging such as FMEA.
• Develop and implement packaging test methods in conjunction with Quality Assurance including test method validation using appropriate statistical techniques.
• Recommend and pursue new packaging process improvement ideas.
• Write technical reports detailing procedures, outcomes, and observations.

Preferable Knowledge, Skills and Abilities

• Experience with heat sealing and testing of Medical Packaging materials such as Tyvek and foil-laminate pouches and an understanding of the relationships between process inputs and final package performance is required.
• Prior experience working in an ISO 9001, ISO 13485, or GMP facility with clean room environments and direct experience with ISO 11607 for sterile packaging is highly preferred.
• Understanding of statistical methods and associated statistical analysis software. Proficiency with Minitab is preferred.
• Ability to design experiments and evaluate data using packaging characterization techniques (seal inspection, seal strength, seal integrity, etc.).
• Ability to be a team player.
• Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.

Education/Experience Requirements for Polymer Engineer:

Required: Bachelor’s degree in Packaging Science or closely related field with at least 5 years of experience in a packaging environment.

Preferred: Bachelor’s or Master’s degree in Packaging Science or closely related field and at least 5 years of experience in a medical and/or sterile product packaging environment.

Environmental Requirements:

Must be able to adapt to multiple indoor work environments (shared office space, shared lab space and production areas).

Working Conditions at Poly-Med, Inc.:

At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.

Physical Requirements:

Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.