New Product Design & Development Engineer


Job Description

Individually contribute to new product design and development projects at the Global Center for Medical Innovation (GCMI). Utilize education and industry experience to create and review high quality deliverables for projects from initiation through delivery of new medical devices. This position will interact on a consistent basis with entrepreneurs, physicians, faculty, students, regulatory agencies, and global professionals to ensure that all requirements are met. This position typically will advise and counsel: students, faculty, project sponsors, regulatory agencies, executives, and professionals. Evaluate risk and ensure all project deliverables follow GCMI Quality Management System procedures. Conducts complex work important to the organization. Works with minimal supervision with wide latitude for independent judgment. Up to 20% travel is required (Several trips of 2-3 days duration). Flexible work schedule, 1-2 days per week remote, 3-4 days in the office. This position will start as a 1099 contractor with the potential to convert to full-time staff (faculty at Georgia Institute of Technology). 

Key Responsibilities

  • Translate user needs and design inputs into engineering specifications.
  • Manage quality systems for medical device development, generate content for Design History Files, and prepare for quality audits.
  • Generate product concepts, assemble prototypes, develop test methods, construct fixtures, and draft test protocols and reports for design verification and validation.
  • Conduct experiments and analyze data with Good Documentation Practices
  • Create novel intellectual properties (patents, trademarks, and proprietary data/information.)
  • Participate in external client communications, project planning, resource allocation, and organizational planning.
  • Management of GCMI’s Quality Systems.
  • Perform other related duties as assigned. 

Education, Specialized Knowledge and Experience

  • Degrees required for this job: Bachelor’s degree biomedical engineering, mechanical engineering, electrical engineering, or related field, or equivalent combination of education and experience.
  • Degrees preferred for this job: Master’s Degree in technical field or MBA with focus on innovation, manufacturing, or product development.
  • Years of experience required for this job: Five or more years of related experience within an established Quality Management System.
  • Years preferred: Seven or more years of relevant experience
  • Certifications or licenses required for this job: N/A
  • Certifications or licenses preferred: Project Management Professional (PMP) certification. SolidWorks certification. 

Specialized Skills

Specialized skills required for this job: Knowledge of medical device regulatory requirements 21 CFR 820 and ISO 13485. Experience working with medical product development and launching new products. Substantial experience using various medical device Quality Systems. Familiarity with the various work streams and documentation to support medical products during and after the development process. 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, 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 be able to handle conflict (both technical and personal).

Specialized skills preferred: Experience with software and app development. Experience designing and fabricating integrated circuits and automated equipment.


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