05 oct
|
Merit Medical
|
Centro-Norte
05 oct
Merit Medical
Centro-Norte
Our team at Merit is growing, and we’re looking for an experienced Labeling Engineer to support labeling development, regulatory compliance, and documentation for our medical device products.
If you have experience in medical device labeling, integral regulations, and cross‑functional collaboration, take a look at this great opportunity.
ESSENTIAL FUNCTIONS PERFORMED
1. Independently evaluates, selects, and applies standard technical techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.
2. Investigates a moderate number of technical variables in completing assignments that have clear and defined objectives.
3. Performs work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents.
4. Works independently on standard projects while assistance is furnished on unusual problems.
5. Receives instructions on specific assignment objectives, complex features and possible solutions.
6. May supervise the work of engineers/technicians or others who assist in specific assignments and work jointly with other engineers.
7. Performs work of some higher technical level for continuing training purposes.
8. Works on special projects, writes ECN's, and creates prototypes under broad direction.
9. May have authority over NCMR’S.
10. Performs other related duties and tasks as required.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
Lifting -- Not to exceed 50 lbs. – local practice may apply.
Writing
Sitting
Standing
Bending
Visual acuity
Color perception
Depth perception
Reading
Field of vision/peripheral
Fine motor skills
Noise
Chemical vapors
SUMMARY OF MINIMUM QUALIFICATIONS
Education and/or experience equivalent to a Bachelor’s Degree in Engineering or technical field related to the department of assignment or industry with five years previous related experience.
3–5+ years of experience in labeling, document control, regulatory, quality, or manufacturing engineering
Experience with IFUs, UDI, packaging artwork, and ECO processes
Strong knowledge of FDA, ISO 13485, and EU MDR requirements
Experience using Oracle ERP and NiceLabel (preferred)
Bilingual English–Spanish
BS Engineering or equivalent
Ability to apply analytical skills and scientific technical principles in problem solving and development.
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
Strong interpersonal and organizational skills and the ability to work effectively as a team member.
Working knowledge of United States and international standards as applicable to the department.
COMPETENCIES
Scientific techniques/evaluation/selection/application
Scientific variable analysis
Plans/surveys/structures/equipment
Supervisory assistance
Special projects/ECN's/prototype creation
NCMR causes/corrective actions/dispositions
COMMENTS
Infectious Control Risk Category II:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.
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📌 Labeling Engineer (Centro-Norte)
🏢 Merit Medical
📍 Centro-Norte