Experience:
1-3 years of experience
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Employment Type:
Full time
Posted:
3/22/2019
Job Category:
Engineering
Associate Engineer
(This job is no longer available)
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Job Description

Job Description SummaryThis 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. The candidate will work on cross-functional teams in an effort to remediate gaps to new EU MDR requirements. The Associate Engineer will contribute to the review of technical documentation, product testing, and analysis of data.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

* 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 project 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.
* Execute testing in support of technical documentation remediation.
* Complete R&D department reports for Post Market Surveillance.

QUALIFICATIONS



To perform this job successfully, 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.

* Must be a self starter and work with minimal supervision.
* Strong critical thinking skills and ability to review large quantities of data to make decisions.
* Ability to organize the priority of work requirements and effectively work with team members to assign, communicate and meet realistic completion dates.
* Proficient in the use of a personal computer with intermediate level of keyboarding skills. Proficient in MS Word, Excel, and databases.
* Strong organizational skills and ability to work in cross functional teams.
* Strong interpersonal skills to include oral and written communication skills.
* Ability to create, review and coordinate reports in support of Post Market Surveillance
* Ability to make and present engineering decisions

EDUCATION and/or EXPERIENCE

* Bachelor's degree in technical field such as biomedical engineering, polymer science, chemistry, chemical engineering, mechanical engineering or other engineering field is required.
* Knowledge and training in project management, QSR, process development, Electronic Databases and/or design control processes is a plus.
* 0-2 years experience in consumer/medical product and process development.



LANGUAGE SKILLS

Ability to read, analyze, and interpret general technical procedures or government regulations. Ability to write protocols, simple reports, and business correspondence.

MATHEMATICAL SKILLS

Ability to perform basic mathematical calculations. Working knowledge of statistics desired.

REASONING ABILITY

This position requires good judgment. All product and process development activities within a team are to be carried out according to the applicable laws and regulations. When in doubt, the incumbent should source out the appropriate information via internal and external resources. In addition, should be able to analyze data and suggests additional courses of action.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear. Specific vision abilities required by this job include close vision and color vision. Some light lifting may be required.

WORK ENVIRONMENT

No special work environment conditions other than minimal exposure to manufacturing environment (i.e. noise, minimal heat and some chemical fume exposure) and laboratory settings.

"This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy. This position will support BD & BARD integration efforts and is anticipated to last for an estimated two years."

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Primary Work LocationUSA GA - Covington BMD

Additional Locations

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