Hybrid R&D Packaging Engineer III

at CONMED Corporation

• Job title: R&D Packaging Engineer III
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Largo, United States

About the role

• R&D Packaging Engineer III creating innovative packaging designs and leading validation testing for medical devices. Collaborating cross-functionally to enhance product quality and meet regulatory standards.

Responsibilities

• Define innovative and high valued products for the business
• Create and develop novel concepts and designs
• Lead the verification and validation testing of these designs
• Fully transfer new devices to manufacturing
• Support the efficient, high-quality design and development of medical device systems
• Work cross-functionally with manufacturing, project management, R&D, procurement, regulatory, marketing, quality, and operations team members, as well as external suppliers
• Develop packaging specifications and associated engineering documents
• Develop packaging testing methods
• Perform, or direct test method validations and train others to use these methods as required
• Perform validation of new or modified packaging designs to appropriate and current regulatory standards
• Work directly with outside suppliers to develop optimal package designs and/or components
• Coordinate and communicate packaging technology and designs with project teams and management staff as part of project management and design control activities
• Identify, review, and evaluate new packaging technology for application to current and future product designs
• Participate in development of risk analysis associated with packaging design and associated processes
• Document all 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 new medical packaging material and perform selection and analysis
• Maintain and improve product quality by performing and documenting robust root cause investigations and implementing effective corrective and preventive actions as part of the CAPA process.
• Improve R&D packaging procedures to improve time-to-market, test lab bandwidth, and lower R&D packaging costs.
• Stay current with worldwide packaging regulations.
• Resolve R&D packaging compliance gaps through thorough testing and/or procedure gaps.

Requirements

• Bachelor of Science degree required. (Major in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Materials Engineering or Packaging Science or a related field strongly preferred)
• 4+ years related packaging engineering work experience
• Understanding of packaging test methods and standards
• Solid strong business and financial acumen and ability to digest and synthesize data quickly
• Ability to lead with influence and develop trusting business relationships across functions and site locations
• Strong technical writing and presentation skills
• Knowledge of standards, Corrective and Preventative Actions (CAPA) and test methods used in the medical device industry
• Hands on 2D / 3D modeling software experience
• Knowledge of statistical analysis tools
• Highly proficient with Microsoft Office Programs (Word, Outlook, Excel, etc.)

Benefits

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
• Employee Stock Purchase Plan -- allows stock purchases at discounted price
• Tuition assistance for undergraduate and graduate level courses