Research Engineer

The Research Engineer is responsible for assisting with Post-Market Clinical and non-Clinical Research efforts at BioHorizons, in conformance with corporate procedures and Quality System Regulations. These duties include developing research protocols, budgets, and ethical approval forms. The Research Engineer shall possess knowledge of anatomy/physiology, biomaterials, and engineering principles to be applied to their essential duties and responsibilities.

Essential Duties and Responsibilities:

• Assist in meeting requirements of European Medical Device Regulations (EU MDR) and US Food and Drug Administration (FDA).
• Assist in the development, review, and ensure compliance of research protocols including but not limited to testing methodologies, statistical analysis, budget, ethical approvals etc.
• Prepare quarterly executive reports on the status of all research studies.
• Manage and oversee in-vitro and in-vivo studies, including animal and human evaluations as part of the development process.
• Communicate with suppliers and clinicians on a regular basis to maintain ongoing update of research studies.
• Assist in optimizing the submission and internal review process of Investigator Initiated Studies.
• Ghost writes and proofread white papers and manuscripts on BioHorizons internal or competitive external devices.
• Investigate and report on industry and non-industry technologies.
• Assist in the development of literature searches and clinical evaluation reports to support existing and new product launches as well as regulatory submissions.
• Collaborate in the design and implementation of new methodologies, materials, and/or processes to bring concepts to market.
• Interface and collaborate with various departments and outside vendors to accomplish assigned tasks.
• Perform other duties as directed.

Qualifications:

• Minimum of 1 year of medical research and medical device design and development experience preferred.
• Proficient in MS Office Suite required.
• Proficient in CAD design software (e.g. SolidWorks) preferred.
• Must possess excellent written and verbal communication skills.
• Ability to interact with colleagues and customers in a professional manner.
• Ability to read and speak multiple languages preferred.
• Experience/familiarity with U.S. FDA, GMP, EU MDR and ISO requirements for the design controls of medical devices preferred.

Education and Experience:

• Bachelor's Degree required in Mechanical Engineering or Biomedical Engineering

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen