R&D Packaging Engineer III

CONMED Corporation • Largo, FL

2d

About The Position

The R&D Packaging Engineer III defines and develops innovative products and packaging concepts, leads verification and validation testing, and transfers new devices to manufacturing. The role supports efficient, high-quality design and development of medical device systems in a fast-paced, LEAN environment. It works cross-functionally 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 packaging test methods; validates packaging designs to applicable regulatory standards; and documents design, development, and testing in compliance with FDA design controls and industry standards. It also evaluates packaging technologies and materials, coordinates designs with project teams, supports risk analysis, and works with suppliers on package designs and components.

The role supports product quality through root-cause investigations, corrective and preventive actions, process improvements, regulatory awareness, and resolution of packaging compliance gaps. Expected travel is 0–20%. The position is not eligible for employer-visa sponsorship.

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

• Prior 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 standards, Corrective and Preventive Actions (CAPA), and test methods used in the medical device industry.
• 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 appropriate and current regulatory standards.
• Work with external 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 packaging technologies for current and future product designs.
• Participate in risk analysis associated with packaging designs and processes.
• Document packaging and labeling design, development, and testing to comply with FDA design control regulations and industry standards for sterile barrier packaging systems and processes.
• Identify and assess medical packaging materials and perform selection and analysis.
• Perform and document root-cause investigations and implement effective corrective and preventive actions through the CAPA process.
• Improve R&D packaging procedures to reduce time-to-market, test lab workload, and packaging costs.
• Stay current with worldwide packaging regulations.
• Resolve R&D packaging compliance gaps through testing and/or procedure improvements.
• Lead verification and validation testing of designs and transfer new devices to manufacturing.

Benefits

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

What This Job Offers

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