Overview

We are looking for a talented individual to join our dynamic Keystone Manufacturing team located in Kalamazoo, MI. The Packaging Engineer is a motivated, self-starter who works collaboratively with other departments within Keystone to develop, problem solve and ultimately deliver packaging solutions to our customers complying with quality and FDA standards. 

The successful candidate must be capable of working with minimal supervision, have a “can do” attitude, possess creative problem-solving skills and be willing to do “whatever it takes” to complete assigned tasks efficiently and effectively. This team member should have excellent interpersonal skills, great attention to detail and be highly organized with the ability to multi task with minimum interruption to work progress.

Job Duties

• Work with internal and external customers throughout the product development and manufacturing transfer processes to identify product appropriate packaging
• Own packaging development and verification and validation testing
• Perform integrity testing on sterile barrier packing as required to support production and new projects
• Create test protocols and reports, as needed for the design history file, and operate within Keystone’s quality system from early development stages to launch and through sustaining support
• Ensure packaging validations execution for new and existing products are ISO 13485 compliant
• Identify cost saving opportunities in current packaging configurations or processes
• Work with Manufacturing Engineering and Operations to optimize packaging and sealing processes
• Proactively front load projects to ensure deadlines are met
• Primary contact for external packaging testing partners and vendors
• Effective and courteous communication to stakeholders, team members, customers and vendors
• Troubleshooting and problem-solving packaging and sealing related issues
• Develop packaging processes utilizing Form, Fill, Seal (FFS) machines, band and bar sealing equipment
• Perform other duties as assigned

Requirements and Qualifications

• Bachelor’s Degree in Packaging Engineering, or similar engineering degree with industry experience, required
• Minimum of 3 years experience in packaging engineering
• Experience and working knowledge of current ISO 13485 standards, QSR, GD, GMP, and ASTM packaging standards
• Familiarity with measurement equipment: calipers, rulers, micrometers, etc.
• Authorized to work in the US without sponsorship
• Must be able to routinely make decisions
• Must have the ability to operate hand tools, inspection equipment, and common office equipment. 
• Must have the ability to operate in a fast-paced environment, sometimes requiring extended work hours, including evenings and weekends as necessary, to ensure minimal interruption to production
• Must have excellent interpersonal communications skills to ensure core corporate values are demonstrated and promoted to all coworkers
• Must have excellent documentation and organizational skills
• Experience with sterile barrier packaging
• Experience working in a clean room
• Experience with single use disposable medical devices
• Experience with seal integrity and seal strength testing is a plus
• References must be provided upon request
• Basic computer skills (word processing, spreadsheets, database)
• Proficient in understanding of Medical Device manufacturing processes desirable

Schedule

Monday through Friday, sometimes requiring extended work hours, including evenings, weekends and holidays to ensure minimal interruption to production. The work environment for this position will be both an office environment and manufacturing work cells and cleanroom environments.

Benefits

• Excellent full-time benefits, including comprehensive medical coverage, dental and vision options
• Company paid life insurance, short term disability and long-term disability insurance
• Retirement savings plan with company match
• Paid time off and holidays, with the ability to schedule a day of volunteering once per quarter
• Flexible work environment, such as occasional work from home, is acceptable and encouraged as business needs and conditions allow
• Professional development opportunities