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Medical Device Risk Management Jobs in Roseville, MN

QARA

Plymouth, MN · On-site

Experience with ISO 14971 risk management activities * Experience with the post market medical device support (complaint or risk analysis) Skill and Experience Details: Minimum Experience Required:

Quality Engineer Medical Device

Roseville, MN · On-site

$100K - $115K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Risk Management & Technical Reviews : Perform and document risk analyses, participate in technical ... Experience with FDA regulations, ISO 13485, and other medical device quality standards.

Quality Engineer Medical Device

Roseville, MN · On-site

$100K - $115K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Risk Management & Technical Reviews : Perform and document risk analyses, participate in technical ... Experience with FDA regulations, ISO 13485, and other medical device quality standards.

Knowledge of medical device risk management standards and methodologies. * Strong technical problem-solving, project leadership, and communication skills. Preferred Qualifications * Project ...

Principal R&D Engineer

Minneapolis, MN

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Knowledge of ANSI/AAMI/ISO 14971 standards for medical device risk management. * Strong problem-solving, communication, and leadership skills; ability to train and mentor team members. * Demonstrated ...

Knowledge of medical risk management, post-market surveillance and global medical device regulations. * Global perspective and familiarity with evolving interventional cardiology and structural heart ...

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Showing results 1-20

Medical Device Risk Management information

See Roseville, MN salary details

$53.6K

$116.2K

$177K

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

As of Aug 12, 2026, the average yearly pay for medical device risk management in Roseville, MN is $116,160.00, according to ZipRecruiter salary data. Most workers in this role earn between $93,700.00 and $134,300.00 per year, depending on experience, location, and employer.

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 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 cities near Roseville, MN are hiring for Medical Device Risk Management jobs? Cities near Roseville, MN with the most Medical Device Risk Management job openings:
Infographic showing various Medical Device Risk Management job openings in Roseville, MN as of August 2026, with employment types broken down into 1% As Needed, 75% Full Time, 19% Part Time, and 5% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $116,160 per year, or $55.8 per hour.

Contractor

Re-posted 24 days ago


Job description

Company Description
Deegit Inc.
Job Description
Job Description:
  • The Clinical Subject Matter Expert (SME) will be responsible for the clinical support of device risk management activities.
  • SME will have the following responsibilities:
  • Review and approval of the clinical workflow definitions for the subject devices
  • Identification of the clinical hazards and associated harms for the subject devices
  • Estimation of the severity and probability of occurrence for the clinically related hazardous situation
  • Development of the clinical benefit statements for the subject device

Key skills and experience:
  • A degree in a clinical related field (RN, MD)
  • 10 years of clinical experience

Additional skills (Desirable)
  • Understanding of device development in an FDA regulated environment
  • Experience with ISO 14971 risk management activities
  • Experience with the post market medical device support (complaint or risk analysis)

Skill and Experience Details:
Minimum Experience Required:
Mandatory Skills: Medical Data Acquisition and Storage Consulting
Desirable Skills: Clinical Systems, Medical Devices - QARA Language Skills: English Language
Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.

Deegit logo

About Deegit

Sourced by ZipRecruiter

Deegit Inc, headquartered in Schaumburg, IL, USA, operates within the IT services industry. They specialize in engaging, mobilizing, and delivering IT talent, with an extensive background spanning more than two decades. Their service portfolio includes IT staff augmentation, direct IT recruitment, and managed services. Established in the late ’90s with a vision to address the growing demand in the IT staffing sector, Deegit has grown rapidly, reflecting strong expertise, robust market understanding, and a deep commitment to customer satisfaction. Their mission is centered around offering superior solutions, harnessing the power of technology, to help their clients thrive in a rapidly evolving digital landscape. The company's notable achievements are reflected in their long-standing partnerships with clients, their high caliber of personnel, and their extensive reach across industries.

Company size

201 - 500 Employees

Headquarters location

Schaumburg, IL, US

Year founded

1993

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