Job Description Summary
This position will lead 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 for legacy products.
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 approximately through May 31, 2023.
ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.
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 QMS 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 QMS requirements.
Execute remediation activities according to project goals, timelines, and within budget.
Execute testing in support of technical documentation remediation.
Design, review, plan, conduct and document laboratory experiments.
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 (preferred), chemical engineering, mechanical engineering or other engineering field is required
Knowledge and training in project management, QMS, process development, Electronic Databases and/or design control processes is a plus
0-2 years experience in a regulated enviornment
Ability to read, analyze, and interpret general technical procedures or government regulations. Ability to write protocols, simple reports, and business correspondence.
Ability to perform basic mathematical calculations. Working knowledge of statistics desired.
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.
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.
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.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. a strong drive for results.
Primary Work Location
USA GA - Covington BMD