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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
packaging engineeringpackaging test methodsvalidation testingrisk analysisroot cause investigationstatistical analysisdesign controlpackaging specificationspackaging technologymedical device systems
Soft skills
business acumendata synthesisleadershiptrust buildingtechnical writingpresentation skillscross-functional collaborationcommunicationproblem-solvinginfluence