Labeling Engineer

Merit Medical; Tijuana; On-site; MXN 520,000 - 760,000; Full time

Job summary

Merit Medical seeks an experienced Labeling Engineer to support labeling development, regulatory compliance, and documentation for our medical devices. The role demands collaboration across functions and strong knowledge of global labeling standards.

The candidate should have 5+ years in labeling, familiarity with FDA/ISO 13485, and bilingual English–Spanish communication skills. This on-site position in Mexico offers exposure to multiple regulatory regimes and cross-border projects.

Qualifications

• 5 years or more of experience in labeling, regulatory, quality or manufacturing engineering.
• 3–5+ years of labeling/document control/regulatory experience.
• Experience with IFUs, UDI, packaging artwork and ECO processes.

Responsibilities

• Evaluate, select and apply standard labeling techniques and comply with regulatory criteria.
• Collaborate cross-functionally to support labeling development and documentation.
• Write ECNs and create prototypes under broad direction; may supervise technicians.

Skills

Labeling engineering

Regulatory compliance

Document control

FDA/ISO knowledge

Bilingual English–Spanish

Education

Bachelor's degree in Engineering

Tools

NiceLabel

Oracle ERP

Job description

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, global 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.