R&D Engineer (Fort Worth, TX)
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
This position is responsible for technical execution within the Biologics and Regenerative Medicine (BRM) franchise that is dedicated to support the end-to-end lifecycle of BRM products (from early innovation & advanced development to launch). Additionally, the employee will support and lead activities/projects during the different phases including (but not limited to): early innovation, technology assessments, advanced development and feasibility testing. As a vital member of the BRM team, s/he will provide scientific expertise, draft and review study designs and reports, contribute to product claims/IP, and/or contractual agreements. S/he will execute and lead various testing activities required during a project lifecycle that will support key program milestones. This includes coordinating completion of study reports and preparation of relevant documents/presentations for various stakeholders. S/he will be a key scientific point of contact to establish strong collaborations internally. This role involves extensive team matrix interactions with colleagues from different franchises (i.e. Sports Medicine, Orthopedics & Trauma, Advanced Wound Management, etc.) and functions (i.e,. Quality. Regulatory Affairs, Manufacturing, etc.).
What will you be doing?
Oversee the design and execution of BRM’s project plans that integrate early innovation & feasibility and product characterization and development to support the pipeline and portfolio programs.
Act as primary contact and provide oversight to CRO/CDMO partners to ensure consistent practices across vendors, groups and sites, communicate and trouble-shoot issues and track/forecast activities.
Preparation and review of protocols, abstracts and manuscripts, study and technical reports for their inclusion in either regulatory and/or marketing support.
Collaborate with cross functional teams (Clinical Affairs, Safety, Regulatory Affairs, QA, QC, Manufacturing, other subject matter experts) to deliver BRM project needs
Maintain current, in-depth product knowledge, including current developments, scientific and clinical literature review, therapeutic and product operation knowledge, as well as related new technologies for technology assessment.
In addition to gaining broader portfolio knowledge, act as subject matter expert on biomaterials and technology to support current products as well as assess new technologies in this field.
Perform or consult on in-vitro test methods, including analytical chemistry and formulation / colloidal chemistry. Hands on experience with analytical equipment and test methods is preferred.
Facilitate medical device development and sustaining through design controls including but not limited to, DHF creation and maintenance, user needs, design inputs, verification & validation testing, and working in a quality management system.
Mentor junior engineers and scientists.
What will you need to be successful?
Bachelor's Degree with 2+ years' experience in a relevant scientific or engineering discipline required
Master’s Degree in a relevant scientific or engineering discipline preferred
Minimum 2 years of relevant experience with demonstrated ability to work in the lab setting and experience with physical chemistry and formulation.
Excellent communication skills and interpersonal/team effectiveness, ability to communicate to various levels of management.
Proven ability to deliver results in a matrix organization and effectively collaborate with leadership.
Physical Demands:
Must be able to stand and/or sit for extended periods of time
Must be able to push, pull, squat, bend, and reach above shoulders
Repetitive use of hands
Ability to view computer screen for extended periods
Must be able to lift and carry objects up to 20lbs
May need to use common hand and power tools
Travel Requirements: 25%
You Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
LI-HYBRID
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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