Senior Engineer — Medical Device Validation & Compliance

Merit Medical; Tijuana; On-site; MXN 550,000 - 750,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical skills

Advanced English

Teamwork

Computer skills

Problem solving

Education

Bachelor's Degree in Engineering or related field

Tools

Spreadsheets

Word processing

Database software

Job description

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.