Research Engineer I

The Global Center for Medical Innovation (GCMI) is the Southeast’s first comprehensive medical technology innovation center. It is a unique entity that functions both as an independent, 501(c)(3) organization and an affiliate of Georgia Tech. GCMI brings together key members of the medical device ecosystem, including universities, research centers, clinicians, early-stage companies, industry, and investors, with the goal of accelerating the commercialization of new medical technologies. It provides a platform for investors to help startups de-risk their technologies efficiently and effectively through commercialization.

Atlanta, GA

Lead projects in medical device development for the Global Center for Medical Innovation (GCMI). Coordinate and monitor multiple small to medium sized medical device/equipment projects from initiation through delivery. May lead aspects of larger projects. Serve as liaison between internal departments and external stakeholders to ensure all project targets and requirements are met. Determine costs and schedules for medical device/equipment projects, ensure work is completed on schedule, and maintain the project budgets. Define the objectives of projects and generate new revenue streams. Support faculty utilization of GCMI resources.

• Translate user needs and design inputs into engineering specifications.


• Maintain compliance with GCMI quality systems, generate content for Design History Files, and prepare for quality audits.


• Generate product concepts, assemble prototypes, construction test methods and validations.
  
• Conduct experiments, execute research programs, and analyze data.


• Create novel intellectual properties (patents, trademarks, and proprietary data/information.)


• Manage external client communications, project planning, resource allocation, and organizational planning.
  
• Directly or indirectly supervise engineering staff.


• Manage GCMI resident companies (clean-rooms, office space, accelerators).
  
• Perform other related duties as assigned.

Bachelor's degree in biomedical engineering, mechanical engineering, or related field.

• Degrees preferred for this job: Master's Degree in technical field or MBA with focus on innovation, manufacturing, or product development.


• Years preferred: 1-2 years of direct medical device development experience in a professional environment


• Certifications or licenses preferred: Project Management Certification (PMP, etc.). Solidworks certification.

Salary commensurate with qualifications.

Specialized skills required for this job: Basic knowledge of the medical device development process and regulatory requirements. Experience in hands-on engineering applications that would require a blended use of contemporary engineering problem solving skills, as well as applied skills. Working knowledge of SolidWorks is required. Applicants should have experience working on teams to solve complex problems, and must be able to organize their thoughts efficiently to communicate with of internal staff, as well as clientele. Applicant should have working knowledge on device fabrication and prototyping utilizing 3D printing technology.

Specialized skills preferred: Knowledge and experience with the following tools: Quality Systems Regulation and the FDA regulatory process, Quality Management Systems and the ISO/EU/CE-Mark regulatory process, documentation practices and document management per regulatory requirements, design verification and validation activities, creation of compliant protocols and reports via MS Office. Basic understanding of patents and generating content for invention disclosures & patent applications. Expertise in building prototypes and/or creating test methods. Experience defining specifications and/or component requirements for medical devices. Must work well in a highly variable and sometimes pressured environment.

Email: [email protected] with any questions

Passing a background check and verification of highest educational degree will be required prior to employment.

Georgia Tech provides equal opportunity to all faculty, staff, students, and all other members of the Georgia Tech community, including applicants for admission and/or employment, contractors, volunteers, and participants in institutional programs, activities, or services. Georgia Tech complies with all applicable laws and regulations governing equal opportunity in the workplace and in educational activities. Georgia Tech prohibits discrimination, including discriminatory harassment, on the basis of race, ethnicity, ancestry, color, religion, sex (including pregnancy), sexual orientation, gender identity, national origin, age, disability, genetics, or veteran status in its programs, activities, employment, and admissions. This prohibition applies to faculty, staff, students, and all other members of the Georgia Tech community, including affiliates, invitees, and guests.

Some traveling to outside meetings and/or conferences will occasionally be required.