Why Merit?
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
Ensures that software used in Merit medical devices, manufacturing systems, and supporting digital platforms meets the highest standards of safety, reliability, and regulatory compliance. Partners closely across departments to ensure that all software—embedded, application-level, cloud, or manufacturing-related—meets design control, risk management, and post-market surveillance expectations.ESSENTIAL FUNCTIONS PERFORMED
- Develops and maintains software quality plans aligned with design controls and global regulatory requirements.
- Ensures compliance with 21 CFR 820.30, ISO 13485, and internal procedures.
- Leads software risk analysis (FMEA, hazard analysis, fault-tree analysis) and CSA risk activities
- Reviews and approves protocols, traceability matrices, and reports; requirements for clarity, completeness, and testability.
- Evaluates and qualifies software suppliers (audits, risk-based assessments).
- Leads investigations for software-related issues and field events.
- Ensures robust change management, impact analysis, and regression strategies.
- Partners on vulnerability management, secure design, and patching strategies.
- Supports trending, field analysis, and risk updates for released software.
- Performs other duties, as assigned.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting -- Not to exceed 50 lbs. – local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Reading
• Field of vision/peripheral
SUMMARY OF MINIMUM QUALIFICATIONS
- Education and/or experience equivalent to a Bachelor’s degree in relevant engineering discipline.
- A minimum of eight (8) years of experience in software assurance or regulated software development.
- Strong knowledge of: IEC 62304, ISO 14971, ISO 13485, 21 CFR Part 820 / QMSR
- FDA software validation and CSA guidance
- Experience with requirements/tools (e.g., Jira, Monday.com)
- Ability to interpret architecture, code structure, and test coverage
PREFERRED QUALIFICATIONS
- Experience in Class II or Class III medical devices.
- Experience with AI/ML in regulated environments.
- Experience with cyber-security standards (e.g., UL 2900).
- Certifications such as ASQ CSQE, ISTQB, Certified Quality Engineer (CQE)
- Experience in independently performing Advanced Operations or manufacturing software validation.
COMPETENCIES
• Interpersonal skills
• Organization
• Written and Verbal Communication
• Problem Solving
COMMENTS
Infectious Control Risk Category III:
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 III states employment and procedures that do not require exposure.
As an eligible Merit employee, you can expect the following:
* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
* Medical/Dental & Other Insurances (eligible the first of month after 30 days)
* Low Cost Onsite Medical Clinic
* Two (2) Onsite Cafeterias
* Employee Garden | Gardening Classes
* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
* 401K | Health Savings Account
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
Skills Required
- Bachelor's degree in a relevant engineering discipline, or equivalent education and experience
- At least eight years of experience in software assurance or regulated software development
- Strong knowledge of IEC 62304
- Strong knowledge of ISO 14971
- Strong knowledge of ISO 13485
- Strong knowledge of 21 CFR Part 820 and QMSR
- Knowledge of FDA software validation and Computer Software Assurance guidance
- Experience with requirements management tools such as Jira or Monday.com
- Ability to interpret software architecture, code structure, and test coverage
- Experience with Class II or Class III medical devices
- Experience with AI/ML in regulated environments
- Experience with cybersecurity standards such as UL 2900
- ASQ CSQE, ISTQB, or Certified Quality Engineer certification
- Experience independently performing advanced operations or manufacturing software validation
Merit Medical Systems, Inc. Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Merit Medical Systems, Inc. and has not been reviewed or approved by Merit Medical Systems, Inc..
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Healthcare Strength — An on‑site medical clinic at headquarters and campus wellness initiatives aim to make care more convenient and affordable for employees and families. Safety training and ongoing wellness programming further reinforce the health offering.
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Retirement Support — A 401(k) Profit Sharing Plan with active employer contributions and discretionary matching provides structured support for long‑term savings. Eligibility and plan participation are clearly established for U.S. employees.
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Equity Value & Accessibility — An employee stock purchase plan with a purchase discount enables accessible ownership participation. A successor plan is slated to replace the legacy program, pending shareholder approval.
Merit Medical Systems, Inc. Insights
What We Do
As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care. Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 300 individuals. Merit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.
