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Manager of Research Engineering

Location:
Birmingham, AL
Company:
BioHorizons Implant Systems, Inc.

Description

Managing all aspects of Post-Market Clinical and non-Clinical Research efforts at BioHorizons in conformance with corporate procedures and Quality System Regulations;
Overseeing aspects of design and development for medical devices at BioHorizons in conformance with corporate procedures and Quality System Regulations;
Adhering with the company's Quality Management System to ensure compliance with applicable regulatory requirements;
Reviewing and assisting in the development of research protocols, testing methodologies, budgets and institutional review approvals;
Investigating and reporting on industry and non-industry technologies;
Being the R&D representative for research scope development;
Developing product specifications, supporting prototype development, creating and executing testing methodologies, and maintaining detailed documentation to evaluate design feasibility;
Submitting ideas for patent filings;
Evaluating/investigating design changes, product complaints, and non-conformances;
Reporting findings and recommendations as per corporate procedures;
Generating design inputs and outputs to support the development process;
Developing Design History Files and supporting subsequent Regulatory submissions;
Being the R&D research representative for quality management system audits by internal and external regulatory authorities;
Creating design verification and validation test plans and reports;
Executing design verification and validation testing;
Generating risk analysis documentation such as Failure Mode and Effects Analysis (FMEA) for new products;
Designing and implementing new methodologies, materials, and/or processes to bring concepts to market;
Managing and participating in in-vitro and in-vivo studies, including animal and human evaluations as part of the development process;
Interfacing and collaborating with Manufacturing, Quality, Regulatory, Research and Development, Sales, Marketing, Accounting, Customer Care, and outside vendors to accomplish assigned tasks; and
Presenting to colleagues and customers on research, products, device design, and applied engineering principles.


Minimum Requirements:

A bachelors degree or its foreign equivalent in Biomedical Engineering, Mechanical Engineering or a closely related field plus 4 years of work experience in Post-Market Clinical and non-Clinical Research in medical device field. This experience (which may be gained concurrently) must include:

4 years of experience in dental medical device design and development;
3 years of experience with SolidWorks CAD design software;
3 years of experience with testing systems and software using MTS and DYNAMESS; and
3 years of experience working with U.S. FDA, GMP and ISO requirements for designing controls of dental medical devices.

Up to 10% of domestic travel. Periodic telecommuting allowed.


Job Location: Birmingham, AL. 40 hours per week, 8:00am-5:00pm. Send resume and letter of application detailing experience to Sandra Feagans, Director, Human Resources, BioHorizons Implant Systems, Inc.,
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