ZipRecruiter

Log In

1

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:

Actalent

Quality Engineer

Minneapolis, MN

$75K - $97K/yr

Experience applying the medical device risk management standard ISO 14971. * Knowledge of global harmonization task force (GHTF) requirements for process validation and related activities. * Solid ...

Actalent

Quality Engineer

Minneapolis, MN

$75K - $97K/yr

Experience applying the medical device risk management standard ISO 14971. * Knowledge of global harmonization task force (GHTF) requirements for process validation and related activities. * Solid ...

Gateway Recruiting

Medical Director

Minneapolis, MN

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

Actalent

Principal Engineer

Minneapolis, MN · Hybrid

$104K - $156K/yr

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

next page

Showing results 1-20

All JobsMedical Device Risk Management JobsMedical Device Risk Management Jobs in Minnesota

Medical Device Risk Management information

Is risk management a good career?

Risk management in the medical device industry involves identifying and mitigating potential safety and compliance issues, which is essential for product development and regulatory approval. It requires strong analytical skills, knowledge of standards like ISO 14971, and often involves collaboration with engineering and quality teams. The field offers opportunities for growth, specialization, and a stable career path due to the importance of safety in healthcare products.

What is the highest paying risk management job?

In the field of medical device risk management, senior roles such as Risk Management Directors or Chief Risk Officers typically have the highest salaries, often exceeding six figures. These positions require extensive experience, certifications like ISO 14971, and leadership skills, reflecting their strategic importance and responsibility within organizations.

How much does a risk manager get paid?

A medical device risk management professional's salary typically ranges from $70,000 to $130,000 annually, depending on experience, certifications, and location. Senior risk managers or those with specialized skills can earn higher salaries, especially in regulated environments requiring knowledge of ISO 14971 and risk assessment tools.

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 risk management in the medical device industry?

Risk management in medical device risk management involves identifying, assessing, and controlling potential hazards associated with medical devices to ensure patient safety and regulatory compliance. Professionals in this field use tools like risk analysis and failure mode effects analysis (FMEA) and often require knowledge of standards such as ISO 14971. Effective risk management is essential throughout the device lifecycle, from design to post-market surveillance.

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 popular job titles related to Medical Device Risk Management jobs in Minnesota? For Medical Device Risk Management jobs in Minnesota, the most frequently searched job titles are:
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
QARA

QARA

Deegit Inc

Plymouth, MN • On-site

Contractor

Posted 6 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

Social media

FacebookTwitter

View All Deegit Jobs

Apply