R&D Packaging Engineer III
R&D Packaging Engineer III
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Job Description
As an R&D Packaging Engineer III you will 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 and fully transfer new devices to manufacturing. Throughout this process you will support the efficient high-quality design and development of medical device systems working cross-functionally with manufacturing project management R&D procurement regulatory marketing quality and operations team members as well as external suppliers. This is a hybrid position in Largo FL.
Duties and responsibilities include:
- Design:
- 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
- Quality:
- 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.
This role requires a driven and responsible team player who can think creatively while keeping business objectives front of mind. If you enjoy working in a cross-functional fast paced LEAN environment with tangible machines processes and medical device products we invite you to apply for consideration!
Required Qualifications:
- 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
Preferred Qualifications:
- Medical device industry experience
Other Attributes:
- 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.)
This position is not eligible for employer based sponsorship.
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
- 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
Know someone at CONMED Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.
Colorado Residents: In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
If you feel you need a reasonable accommodation pursuant to the ADA you are encouraged to contact us at option #5.
Employment Type
Full-Time
