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Medical Device Risk Management Jobs in Rowlett, TX

Ztek Consulting INC

Firmware Engineer

Plano, TX · On-site

Excellent understanding of ISO 14971 medical device risk management. * Working experience with ISO 13485, ISO 9001 Quality management standard practices. * Experience with medical device development

Kyyba Inc

Medical Device Quality Technician

Irving, TX · On-site

$21 - $21.98/hr

... medical device assembly. o May operate more advanced measuring instruments as needed. * Perform ... Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other ...

New

Freeman

Enterprise Risk Management Analyst

Dallas, TX · Hybrid

Summary Professional analyst role that supports the Enterprise Risk Management (ERM) program under ... Medical, Dental, Vision Insurance * Tuition Reimbursement * Paid Parental Leave * Life, Accident ...

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All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Rowlett, TX

Medical Device Risk Management information

See Rowlett, TX salary details

$46.2K

$100.1K

$152.5K

How much do medical device risk management jobs pay per year?

As of Sep 10, 2026, the average yearly pay for medical device risk management in Rowlett, TX is $100,091.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,800.00 and $115,700.00 per year, depending on experience, location, and employer.

What is medical device risk management?

Medical device risk management is the systematic process of identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle. This process ensures that potential hazards are minimized to protect patient safety and comply with regulatory standards, such as ISO 14971. Risk management includes activities like risk assessment, implementing controls, monitoring, and documenting all steps to demonstrate compliance. It is a critical function in the design, manufacturing, and post-market phases of medical device development.

How does a medical device risk management professional typically collaborate with cross-functional teams during the product development lifecycle?

Medical Device Risk Management professionals work closely with engineering, regulatory affairs, quality assurance, and clinical teams to identify, assess, and mitigate potential risks associated with medical devices. They participate in design reviews, facilitate risk assessments such as FMEA, and ensure that risk controls are effectively implemented and documented according to regulatory standards like ISO 14971. Regular communication and collaboration are essential to align risk management activities with project timelines and compliance requirements, ensuring patient safety and product success.

What are the key skills and qualifications needed to thrive in medical device risk management, and why are they important?

To thrive in Medical Device Risk Management, you need a solid background in engineering or life sciences, a thorough understanding of regulatory standards (such as ISO 14971), and experience in risk assessment processes. Familiarity with risk management software, quality management systems, and relevant regulatory databases is typically required, along with certifications like Certified Risk Manager (CRM) or RAC. Strong analytical thinking, attention to detail, and effective communication are crucial soft skills for evaluating risks and collaborating with cross-functional teams. These competencies ensure the safety and compliance of medical devices, protecting both end-users and the company from regulatory or safety issues.

What is the difference between Medical Device Risk Management vs Medical Device Quality Assurance?

AspectMedical Device Risk ManagementMedical Device Quality Assurance
Primary FocusIdentifying, evaluating, and mitigating risks associated with medical devicesEnsuring products meet quality standards and regulatory requirements
CertificationsISO 14971, RAPS certifications often preferredISO 13485, regulatory compliance certifications
Work EnvironmentDesign and development teams, risk analysis meetingsManufacturing, inspection, and quality control departments
Industry UsageUsed throughout product lifecycle for safety managementUsed to maintain product quality and compliance

While both roles are essential in the medical device industry, Risk Management focuses on minimizing safety risks throughout the product lifecycle, whereas Quality Assurance ensures products consistently meet quality and regulatory standards. Understanding these differences helps professionals align their skills with industry needs.

What cities near Rowlett, TX are hiring for Medical Device Risk Management jobs?

Cities near Rowlett, TX with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you
Infographic showing various Medical Device Risk Management job openings in Rowlett, TX as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $100,091 per year, or $48.1 per hour.

Bioinformatics Pipeline Test Engineer

Prosper, TX • On-site

Vytwo
See more jobs at Vytwoexternal

Full-time

Re-posted 12 days ago

Key responsibilities

  • Help with verification and validation protocols and generate test reports for software solutions used in medical devices and LDT products.

  • Assist in translating user and software requirements into executable verification and validation protocols, focusing on various aspects of the software lifecycle.

  • Support the creation of design controls and software documentation, participate in risk assessments, and ensure compliance with regulatory requirements.

Job description

Position Title: Bioinformatics Pipeline Test Engineer
 Domain EXP: (Healthcare Domain)
Experience: 2+ Years of exp
 Location: San Diego CA “Onsite client office”
Duration: 6 Months
JD in brief:
For these candidates, it’s imperative to have NGS pipeline experience or education. Working with Illumina sequencing data, AWS healthomics, Nextflo Type experience working on secondary analysis pipelines
 
Essential Duties:
  • VERIFICATION AND VALIDATION
    •  With direction and guidance from the team lead, help with verification and validation protocols and generate test reports for multiple software solutions used in medical devices and LDT products. 
    • Aid in translation of user and software requirements into executable software verification and validation protocols focusing on various aspects of the software lifecycle.
    • Collaborate with bioinformatics scientists and operations to identify test inputs and understand the development of algorithmic test strategy, testing tools, and testing methodology.
    • Test product functionality and/or confirm product capabilities. 
  • DESIGN CONTROLS 
    1. With direction and guidance from the team lead, help with design controls and appropriate software documentation (e.g. software requirements and/or specifications, architecture documents, software design details doc) for medical device software lifecycle. 
    2. Learn and apply best practices for LDT software and create and manage all applicable documentation. 
    3. Participate in risk assessments for software products, including identification of potential risk mitigations and traceability to software requirements. 
    4. Help with the creation of software documentation, compatible with regulatory requirements. 
  • Utilizing standardized procedures and practices, work on assignments individually and with project team members to achieve department and project objectives and meet deadlines.
  • Exercise excellent verbal and written communication skills with the ability to communicate basic technical information.
  • Work towards challenging goals in a fast-moving environment.
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
  • Support and comply with the company’s Quality Management System policies and procedures.
  • Maintain regular and reliable attendance.
  • Ability to act with an inclusion mindset and model these behaviors for the organization.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
  • Ability and means to travel 10% between local Exact Sciences locations. 
  • Ability to travel 5% of working time away from work location, may include overnight/weekend/international travel. 
 Minimum Qualifications
  • B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties. 
  • Familiarity with the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications.
  • Familiarity with production software development lifecycle.
  • Familiarity with best practices for software development (such as Git, agile, code reviews, CI/CD). 
  • Ability to effectively communicate software system designs. 
  • Excellent communication skills (both written and oral) with the ability to communicate complicated ideas and information effectively at all levels. 
  • Demonstrated ability to perform the essential duties of the position with or without accommodation.
 Preferred Qualifications
  • Experience with programming languages, ideally Python. 
  • Familiar with automated software testing, preferably in the context of medical devices software such as bioinformatics analysis pipelines. 
  • Familiarity with container orchestration concepts and systems, e.g. Docker, Kubernetes, etc. 
  • Familiar working with cloud platforms (AWS, GCP, Azure).
  • Familiarity within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry, developing CFR 21 Part 11 and IEC 62304 compliant software. 
  • Familiarity with medical device requirements such as Quality System Regulation (21 CFR part 820) ISO 14971 Medical Device Risk Management, ISO 13485, etc. Work experience is strongly preferred. 
  • Familiarity with bioinformatics analysis pipeline frameworks. 
  • Familiarity with software related Cybersecurity risk management such as FDA Cybersecurity guidance, IEC27000 series, IEC 15408, etc. as well as software audits is a plus.
Familiar with managing requirements in a validated RM tool such as JAMA, DOORS, etc.