R&D Engineer II
As an R&D Engineer II, 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.
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.
Qualifications:
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!
Candidates will be evaluated based on the following criteria:
- Bachelor of Science degree required. Major in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Materials Engineering or Packaging Science or a related field strongly preferred
- 2+ years related engineering work experience
- Medical device industry experience preferred
- 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 visa sponsorship.
Benefits:
CONMED offers
- 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) -- company match dollar for dollar up to 7% Employee stock purchase plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.