Engineer III

Merit Medical; Tijuana; Presencial; MXN 550.000 - 750.000; Jornada completa

Descripción de la vacante

Merit Medical seeks a technically proficient engineer to independently evaluate and apply standard techniques for medical device projects. You will investigate variables, work on standard plans, and write ECNs and prototypes under broad direction.

Strong English, five years of related experience, and knowledge of ISO 13485 and MDR are required, along with experience leading small projects and ensuring regulatory compliance in a medical device environment.

Formación

• Education equivalent to a Bachelor's Degree in Engineering or related field with five years of related experience.
• 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.

Responsabilidades

• Evaluate and apply standard technical techniques, procedures, and criteria with minor adaptations.
• Investigate a moderate number of technical variables to complete defined assignments.
• Perform work with conventional plans and precedents with few complex features.
• Work independently on standard projects while guidance is available for unusual problems.
• Possibly supervise engineers/technicians on specific assignments and collaborate with other engineers.
• Write ECNs and create prototypes under broad direction.
• Engage in special projects as required.
• May have authority over NCMRs.
• Perform other related duties as required.

Conocimientos

Analytical skills

Advanced English

Teamwork

Computer skills

Problem solving

Educación

Bachelor's Degree in Engineering or related field

Herramientas

Spreadsheets

Word processing

Database software

Descripción del empleo

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.