Engineer II

Merit Medical Systems, Inc.•South Jordan, UT

12d•Onsite

About The Position

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world. WORK SHIFT DAY (United States of America) SUMMARY OF DUTIES Performs routine and moderately complex engineering work supporting the manufacture, validation, and sustainment of medical devices with electronic and electro‑mechanical content. Works under broad supervision to support new product introductions, transferred or acquired products, and existing product lines, including collaboration with contract manufacturers to ensure product quality, compliance, and manufacturability. ESSENTIAL FUNCTIONS PERFORMED Supports manufacturing engineering activities for medical devices with electronic, electro‑mechanical, and software‑enabled components, including both newly acquired products and existing Merit product lines. Provides engineering support for new or early‑release products, including participation in process development, process validation, manufacturing readiness, and production ramp-up activities. Works closely with third‑party contract manufacturers to ensure products are built in accordance with specifications, drawings, and quality system requirements; supports issue resolution and continuous improvement activities. Investigates and troubleshoots manufacturing, test, and field issues using structured problem‑solving methods; supports root cause analysis, corrective actions, and documentation of findings. Reviews, interprets, and applies engineering documentation such as drawings, specifications, bills of material, test methods, and work instructions related to electronic assemblies and systems. Supports engineering change activities, including evaluation of impacts, preparation of documentation (e.g., ECNs), and coordination with cross‑functional stakeholders. Assists in verification and validation activities, including test execution, data analysis, and documentation, particularly for products in early lifecycle stages. Collaborates with Quality, Regulatory, Operations, and Supply Chain functions to support compliance with applicable standards and internal procedures for medical devices. Provides technical support for existing products where electronic expertise is required or beneficial, including sustaining engineering and continuous improvement efforts. Gains working familiarity with software and firmware used within supported products and contributes to documentation, impact assessment, or verification activities as appropriate; exposure to software lifecycle standards such as IEC 62304 is beneficial but not required to lead software development. Performs other related duties and special projects as assigned.

Requirements

Bachelor’s degree in Electrical Engineering, Electrical Engineering Technology, or a related engineering discipline; equivalent combination of education and experience may be considered.
Typically 2–5 years of engineering experience in a manufacturing, product support, or regulated industry environment.
Experience with electronics, electro‑mechanical assemblies, or electronic systems; medical device experience is strongly preferred.
Familiarity with manufacturing processes, test methods, and troubleshooting techniques for electronic or electro‑mechanical products.
Ability to apply engineering principles and analytical problem‑solving skills to practical manufacturing and product issues.
Experience working with cross‑functional teams and external suppliers or contract manufacturers is preferred.
Working knowledge of regulated quality systems and applicable standards (e.g., FDA QSR, ISO 13485); familiarity with software or firmware lifecycle standards such as IEC 62304 is a plus.
Demonstrated computer skills, including standard engineering and office software tools.
Strong communication, organizational, and teamwork skills.

Nice To Haves

Familiarity with software or firmware lifecycle standards such as IEC 62304 is a plus.

Responsibilities

Supports manufacturing engineering activities for medical devices with electronic, electro‑mechanical, and software‑enabled components, including both newly acquired products and existing Merit product lines.
Provides engineering support for new or early‑release products, including participation in process development, process validation, manufacturing readiness, and production ramp-up activities.
Works closely with third‑party contract manufacturers to ensure products are built in accordance with specifications, drawings, and quality system requirements; supports issue resolution and continuous improvement activities.
Investigates and troubleshoots manufacturing, test, and field issues using structured problem‑solving methods; supports root cause analysis, corrective actions, and documentation of findings.
Reviews, interprets, and applies engineering documentation such as drawings, specifications, bills of material, test methods, and work instructions related to electronic assemblies and systems.
Supports engineering change activities, including evaluation of impacts, preparation of documentation (e.g., ECNs), and coordination with cross‑functional stakeholders.
Assists in verification and validation activities, including test execution, data analysis, and documentation, particularly for products in early lifecycle stages.
Collaborates with Quality, Regulatory, Operations, and Supply Chain functions to support compliance with applicable standards and internal procedures for medical devices.
Provides technical support for existing products where electronic expertise is required or beneficial, including sustaining engineering and continuous improvement efforts.
Gains working familiarity with software and firmware used within supported products and contributes to documentation, impact assessment, or verification activities as appropriate; exposure to software lifecycle standards such as IEC 62304 is beneficial but not required to lead software development.
Performs other related duties and special projects as assigned.