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Medical Device Risk Management Jobs in Connecticut

Experience in medical risk management, insurance, and/or legal matters in a hospital-based environment (desirable) * Clinical background and management/leadership experience (preferred) * Strong ...

Quality Engineer III

Bethel, CT · On-site

$65K - $102K/yr

Join Resonetics and be part of a team that's redefining medical device manufacturing. If you're ... management and risk mitigation tools and practices. * Leads and/or contributes to root cause ...

Quality Engineer III

Bethel, CT · On-site

$74K - $95K/yr

Join Resonetics and be part of a team that's redefining medical device manufacturing. If you're ... management and risk mitigation tools and practices. * Leads and/or contributes to root cause ...

Complete additional tasks or special assignments as directed by management. Qualifications & Skills ... Previous experience in medical device or regulated manufacturing environments is a plus.

Quality Engineer III

Bethel, CT · On-site

$74K - $95K/yr

Join Resonetics and be part of a team that's redefining medical device manufacturing. If you're ... management and risk mitigation tools and practices. * Leads and/or contributes to root cause ...

Excellent communication and stakeholder management skills * Proven ability to lead and optimize vendor risk programs Illustrative Benefits: * 100% company paid medical premiums * 17 company paid ...

Excellent communication and stakeholder management skills * Proven ability to lead and optimize vendor risk programs Illustrative Benefits: * 100% company paid medical premiums * 17 company paid ...

Excellent communication and stakeholder management skills * Proven ability to lead and optimize vendor risk programs Illustrative Benefits: * 100% company paid medical premiums * 17 company paid ...

Excellent communication and stakeholder management skills * Proven ability to lead and optimize vendor risk programs Illustrative Benefits: * 100% company paid medical premiums * 17 company paid ...

Maintain risk registers and contingency plans * Apply Lean, Six Sigma, and continuous improvement ... Minimum 5 years of experience in project / program management of medical device development. * Must ...

Showing results 21-40

Medical Device Risk Management information

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

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

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

Cities in Connecticut with the most Medical Device Risk Management job openings:

Infographic showing various Medical Device Risk Management job openings in Connecticut as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.

Full-time

Re-posted 12 days ago


Trinity Health rating

6.6

Company rating: 6.6 out of 10

Based on 354 frontline employees who took The Breakroom Quiz

569th of 887 rated healthcare providers


Job description

Employment Type:Full timeShift:Day ShiftDescription:On Site position requires RN License

Position Purpose

The Risk Manager is responsible for overseeing and administering the facility's risk management program across both inpatient and outpatient settings. This role supports a culture of safety and quality by leading risk identification, investigation, and mitigation activities while ensuring compliance with Joint Commission standards and applicable state and federal regulations. The Risk Manager works collaboratively with clinical leadership, legal counsel, and the Risk Management Team to promote patient safety, minimize loss, and protect the organization's assets.

What You Will Do

  • Administer the facility's risk management program on a day-to-day basis.

  • Participate in facility-wide systems for risk identification, investigation, and reduction, including incident report and medical record reviews.

  • Conduct and/or coordinate Root Cause Analyses (RCAs), safety event reviews, and investigations; develop and implement corrective action plans to prevent recurrence.

  • Participate in daily safety huddles and recurring safety and risk management meetings.

  • Maintain and analyze risk management data, statistics, and files in compliance with Joint Commission, state, and federal requirements while promoting maximum confidentiality.

  • Verify the accuracy, availability, and security of key documentation including medical records, billing records, policies and procedures, incident reports, and medical examiner reports.

  • Inform leaders of occurrences, findings, trends, and risk management recommendations; provide feedback to directors and department leaders to support risk reduction efforts.

  • Assist clinical chairs and department heads in designing and implementing effective risk management programs.

  • Work closely with legal counsel to coordinate investigations, manage claims against the facility, and interface with defense counsel as needed.

  • Maintain general knowledge of facility insurance programs and collaborate with the Risk Management Team on insurance-related matters.

  • Proactively analyze patient safety concerns and medical error trends to reduce organizational and financial risk.

Minimum Qualifications

  • Bachelor's degree in Nursing, Healthcare Administration, or a related field (required)

  • Master's degree in Nursing, Healthcare, or a related field (preferred)

  • Connecticut RN license (preferred)

  • Experience in medical risk management, insurance, and/or legal matters in a hospital-based environment (desirable)

  • Clinical background and management/leadership experience (preferred)

  • Strong understanding of hospital and patient care operations, Public Health Code regulations, Joint Commission standards, and FDA and OSHA regulations

  • Excellent interpersonal, communication, relationship management, conflict negotiation, and problem-solving skills

Position Highlights & Benefits

  • Full-time, day-shift schedule (Monday-Friday)

  • Competitive compensation

  • Excellent benefits starting on Day 1

About Saint Francis Hospital

Saint Francis Hospital is committed to exceeding the expectations of our patients and families by delivering world-class service in a progressive, people-centered, and compassionate healthcare environment. Licensed for 617 beds and 65 bassinets, Saint Francis is a major teaching hospital and the largest Catholic hospital in New England

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.


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About Trinity Health

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Trinity Health Ann Arbor is a 537 -bed teaching hospital located on 340 acre campus. Recognized by IBM Watson as a Top 100 Hospital and #1 Teaching Hospital, Trinity Health Ann Arbor has been a leading health care provider for more than 100 years. Trinity Health has received numerous local and national awards in recognition of our leadership, quality outcomes, and clinical excellence.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Livonia, MI, US