16 ago
|
Merit Medical
|
Centro-Norte
16 ago
Merit Medical
Centro-Norte
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 equivalent to a Bachelor's Degree in Engineering or technical field related to the department of assignment or industry with five 5 years previous related experience (title degree is required).
Advanced English level
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.
Strong experience in material changes, including risk assessments, validations, and supporting documentation.
Experience leading low- to medium-impact projects, ensuring compliance with scope, timelines, and regulatory objectives.
Knowledge and experience in validations within the medical device industry, including the development and execution of IQ, OQ, and PQ protocols .
Experience developing and executing validation strategies for product, process, or material changes.
Knowledge of ISO 13485 requirements and practical application within a regulated environment.
Knowledge of European Medical Device Regulation (MDR) requirements, preferably with direct involvement in related projects.
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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📌 Engineer III (Centro-Norte)
🏢 Merit Medical
📍 Centro-Norte