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Job Title: EUMDR Engineer Location: 30014 Covington, GA Duration: Contract Job description: This position assists in leading project teams and/or provides technical effort toward the remediation of technical documentation in support of product registrations in the European Union. The position requires the development of an understanding of medical device markets and regulations. This position requires strong leadership and project management experience. The candidate will lead cross-functional teams in an effort to remediate gaps to new EU MDR requirements. Essential Job Functions:
Assist in leading team members through the EU MDR gap remediation projects. Projects will require remediation to design documents, creation of rationales, creation of specifications, define testing protocols, labeling updates, and compliance with QSR requirements.
Manage complex project programs and execute large technical efforts across multiple functional groups.
Leadership of external and cross-functional partners.
Learn EU MDR requirements and how to apply to new and existing technical documentation.
Assist in ensuring the QSR compliance of design control process in product development.
Knowledge and/or ability to learn Design Control and other QSR requirements.
Execute remediation activities according to project goals, timelines, and within budget.
Complete R&D department reports for Post Market Surveillance.
Basic Qualifications: An individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
Strong interpersonal skills required in the areas of verbal and written communications, customer focus, telephone manner, time management, professionalism, coaching, influencing, and team building.
Proficient in the use of a personal computer with intermediate level of keyboarding skills and proficiency in Microsoft Word, Microsoft Excel, Microsoft Power Point, Microsoft Project, Microsoft Access.
Strong listening and assessment skills.
Strong questioning & problem-solving skills.
Additional Desirable Qualifications, Skills, and Knowledge
LANGUAGE SKILLS: Any Spanish knowledge is a plus
MATHEMATICAL SKILLS
REASONING ABILITY
Education and/or Experience:
BS degree in a technical field such as biomedical engineering, polymer science, chemistry, chemical engineering, mechanical engineering or other engineering field is required.
Knowledge and training of project management, QSR, process development and/or design control processes.
2-4 years of experience in consumer/medical product and process development. Keywords: “EUMDR”, “Medical device” If your skills match these requirements, please send your resume to for immediate consideration. Please be assured that your resume will be reviewed and you will be contacted if there is an interest in your background and experience. Candidates should e-mail resume to address above. Be sure to reference the job number and title in the subject line.
