R&D Packaging Engineer III

CONMED Corporation • Largo, FL

4d

About The Position

The R&D Packaging Engineer III defines innovative, high-value products for the business; creates and develops novel packaging concepts and designs; leads verification and validation testing; and transfers new devices to manufacturing. The role supports efficient, high-quality development of medical device systems in a cross-functional, fast-paced LEAN environment, partnering with manufacturing, project management, R&D, procurement, regulatory, marketing, quality, and operations teams, as well as external suppliers.

The position develops packaging specifications and engineering documents, designs and validates Sterile Barrier Systems (SBS), develops and validates packaging test methods, and evaluates new packaging technologies and materials. It documents packaging and labeling design, development, and testing in compliance with FDA design-control regulations and applicable industry standards. The engineer also supports packaging risk analysis, supplier collaboration, project design-control activities, quality investigations and corrective actions, process improvement, and ongoing compliance with worldwide packaging regulations.

Requirements

• Bachelor’s degree in Packaging Science or equivalent engineering degree.
• Five years of related packaging engineering work experience in the medical device industry.

Nice To Haves

• Experience designing and validating Sterile Barrier Systems (SBS).
• Understanding of packaging test methods and standards.
• Strong business and financial acumen and ability to quickly digest and synthesize data.
• Ability to lead through influence and develop trusting business relationships across functions and site locations.
• Strong technical writing and presentation skills.
• Knowledge of medical-device-industry standards, CAPA, and test methods.
• Hands-on experience with 2D/3D modeling software.
• Knowledge of statistical analysis tools.
• High proficiency with Microsoft Office programs, including Word, Outlook, and Excel.

Responsibilities

• Develop packaging specifications and associated engineering documents.
• Design and validate Sterile Barrier Systems (SBS).
• Develop packaging testing methods, perform or direct test-method validations, and train others to use the methods as needed.
• Validate new or modified packaging designs to applicable current regulatory standards.
• Work with outside suppliers to develop optimal package designs and components.
• Coordinate and communicate packaging technology and designs with project teams and management as part of project management and design-control activities.
• Identify, review, and evaluate new packaging technology for current and future product designs.
• Participate in risk analysis for packaging designs and associated processes.
• Document packaging and labeling design, development, and testing in compliance with FDA design-control regulations and industry standards for sterile barrier packaging systems and processes.
• Identify and assess new medical packaging materials and perform selection and analysis.
• Maintain and improve product quality by conducting and documenting root-cause investigations and implementing effective corrective and preventive actions through the CAPA process.
• Improve R&D packaging procedures to reduce time to market, test-lab workload, and R&D packaging costs.
• Stay current with worldwide packaging regulations.
• Resolve R&D packaging compliance gaps through testing and/or procedure improvements.

Benefits

• Competitive compensation.
• Medical, dental, vision, and prescription coverage.
• Short- and long-term disability and life insurance, fully paid by CONMED.
• 401(k) retirement savings plan with dollar-for-dollar matching and potential matching of up to 7% per pay period.
• Employee Stock Purchase Plan with discounted stock purchases.
• Tuition assistance for undergraduate and graduate courses.
• Employee Referral Program incentives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior