The Clinical 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 institutional review approvals. Clinical Research Engineer shall possess knowledge of anatomy/physiology, biomaterials, and engineering principles to be applied to their essential duties and responsibilities.
In addition, the Clinical Research Engineer is able to assist in aspects of design and development for medical devices at BioHorizons in conformance with corporate procedures and Quality System Regulations. These duties include developing medical device designs and prototypes, detailed specifications and design for manufacturability design verification and validation activity.
The responsibilities of this position include, but may not be limited to the following:
Assist in meeting requirements of future EU MDR. Adhere with the company's Quality Management System to ensure compliance with applicable regulatory requirements
Aid in the development of research protocols, testing methodologies, budgets and institutional review approvals.
Investigate and report on industry and non-industry technologies
Assist in developing product specifications, support prototype development, create and execute testing methodologies, and maintain detailed documentation to evaluate design feasibility
Help evaluate/investigate design changes, product complaints, and non-conformances; effectively report findings and recommendations as per corporate procedures
Help generate design inputs and outputs to support the development process
Assist in the development of Design History Files and support subsequent Regulatory submissions
Create design verification and validation test plans and reports
Support and execute design verification and validation testing
Help generate risk analysis documentation such as Failure Mode and Effects Analysis (FMEA) for new products
Collaborate in the design and implementation of new methodologies, materials, and/or processes to bring concepts to market
Help manage and participate in in-vitro and in-vivo studies, including animal and human evaluations as part of the development process
Interface and collaborate with various departments and outside vendors to accomplish assigned tasks
Occasional overnight travel may be necessary
Perform other duties as directed.
Other duties as assigned
The ideal candidate for this position will possess the following qualifications:
Bachelor's Degree required - Mechanical Engineering, BioMedical Engineering preferred
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
Ability to interact with colleagues and customers in a professional manner
Ability to read and speak multiple languages preferred
Must possess good written and verbal communication skills
Experience/familiarity with U.S. FDA, GMP, EU MDR and ISO requirements for the design controls of medical devices preferred
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.