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Medical Device Risk Management Jobs in Minnesota

Deegit Inc

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:

BEPC INC

Be Seen First

Medical Device Assembler

Plymouth, MN · On-site

$16.75 - $18.75/hr

Support applicable Quality Management System (QMS), Environmental Management System (EMS), and ... Medical device manufacturing experience. * Previous microscope assembly or inspection experience.

Cynet Group

Medical Device Assembler

Minneapolis, MN · On-site

$16 - $19/hr

... medical device assemblies. * Performs routine assignments according to specified and/or ... Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals ...

Cynet

Medical Device Assembler

Minneapolis, MN

$16 - $19/hr

... medical device assemblies. * Performs routine assignments according to specified and/or ... Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals ...

Konik

Principal R&D Engineer

Minneapolis, MN · On-site

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 ...

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Medical Device Risk Management information

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 job categories do people searching Medical Device Risk Management jobs in Minnesota look for?

The top searched job categories for Medical Device Risk Management jobs in Minnesota are:

What cities in Minnesota are hiring for Medical Device Risk Management jobs?

Cities in Minnesota 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 Minnesota as of September 2026, with employment types broken down into 67% Full Time, and 33% Contract. Highlights an 67% In-person, and 33% Hybrid job distribution.

QARA

Plymouth, MN • On-site

Deegit Inc
Recruiting and Staffing Services • 201 - 500 employees
Learn more about Deegit Incexternal

Contractor

Re-posted 21 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.
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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.

Industry

Recruiting and staffing services

Company size

201 - 500 Employees

Headquarters location

Schaumburg, IL, US

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