Quality Engineer Medical Device Entry Level Jobs

Job Summary:

The Cybersecurity Quality Engineer supports the integration of cybersecurity requirements into the product development lifecycle and quality management system for Masimo medical device products. Working under the guidance of senior quality, software, and cybersecurity team members, this role assists in ensuring cybersecurity-related activities are documented, traceable, and executed in accordance with applicable regulatory requirements, quality system procedures, and internal standards. This is an early-career engineering role suited for an individual seeking to develop specialized experience at the intersection of quality systems, design controls, software quality, and medical device cybersecurity.

Duties & Responsibilities:

• Support execution of cybersecurity quality activities across assigned product development programs, including documentation review, milestone tracking, and quality record maintenance. 
• Assist in the preparation, review, and maintenance of cybersecurity-related design control documentation, including threat modeling records, vulnerability assessments, security risk analyses, cybersecurity protocols, and test reports. 
• Maintain traceability between cybersecurity requirements, software design outputs, mitigation activities, and verification/validation records within the Design History File (DHF). 
• Support authoring, review, and periodic updates of cybersecurity-related quality system procedures, work instructions, templates, and documentation standards. 
• Assist in cybersecurity vulnerability monitoring and post-market surveillance activities, including tracking disclosed vulnerabilities, supporting impact assessments, and documenting remediation activities. 
• Support management of cybersecurity-related nonconformances, CAPAs, deviations, and engineering changes through the quality management system, ensuring accurate documentation and timely follow-up. 
• Participate in cross-functional design reviews, cybersecurity risk reviews, and project meetings, supporting quality representation for cybersecurity-related topics. 
• Collaborate with R&D, Software Engineering, Regulatory Affairs, Product Security, and Quality teams to support consistent application of cybersecurity quality requirements across development activities. 
• Support preparation of cybersecurity documentation required for audits, regulatory submissions, inspections, and internal quality reviews. 
• Assist in evaluation of third-party software components, open-source software dependencies, and Software Bill of Materials (SBOM) documentation to support cybersecurity traceability and risk awareness. 
• Support internal audits, readiness activities, and documentation reviews related to cybersecurity quality and design control compliance. 
• Stay current with evolving regulatory guidance, industry standards, and cybersecurity best practices relevant to medical device development.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, Software Engineering, or related technical discipline. 
• 0-3 years of experience in quality engineering, software quality, cybersecurity, product security, or related engineering field; relevant internship, co-op, or project-based experience in regulated environments will be considered. 
• Foundational understanding of cybersecurity concepts including vulnerability management, threat modeling, software security, network security, and secure development principles. 
• Familiarity with quality systems, design controls, software lifecycle documentation, or regulated engineering processes. 
• Strong attention to detail and ability to manage documentation accurately. 
• Effective written and verbal communication skills. 
• Ability to manage multiple tasks and priorities in a dynamic, cross-functional environment.

Preferred Qualifications:

• Exposure to medical device, healthcare technology, embedded systems, or regulated software environments. 
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, FDA cybersecurity guidance, or related regulatory expectations. 
• Awareness of standards such as AAMI TIR57, IEC 62304, IEC 81001-5-1, or NIST cybersecurity frameworks. 
• Exposure to Software Bill of Materials (SBOM), software traceability, or software quality documentation practices. 
• Foundational knowledge of software validation, software quality assurance, or secure SDLC practices. 
• Security+, ISC2 CC, or similar entry-level cybersecurity certification is a plus.

Education:

Bachelor's degree in Computer Engineering, Computer Science, Electrical Engineering, Biomedical Engineering, Software Engineering, or related technical discipline, or equivalent combination of education and experience.

Compensation: The anticipated salary range for this position is $85,000 -$105,000.  Actual placement within the range is dependent on multiple factors, including but not limited to skills, experience and internal equity. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

• Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center, Cafe. All benefits are subject to eligibility requirements.

• Ability to read, write, and communicate effectively in English. 
• Ability to interpret technical documents, engineering data, schematics, and written procedures. 
• Ability to clearly document technical findings and effectively communicate across cross-functional teams.

• This position primarily works in an office environment and requires frequent sitting, standing, and walking. Daily use of a computer and other digital devices is required. This role may require standing for extended periods when facilitating meetings, supporting laboratory activities, or walking through facilities. 

• Must be able to move throughout office, laboratory, and light manufacturing environments as needed to support design reviews, product inspections, audits, and cross-functional collaboration. 

• Occasional lifting and carrying of materials or equipment up to 25 lbs. may be required. 

• Domestic and international travel up to 20-25% may be required to support supplier visits, audits, customer activities, or program-related meetings. 

• The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Masimo is proud to be an EEOE/, M/F/D/V, and we are committed to Diversity at the corporate level.