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Medical Device Risk Management Jobs in Lees Summit, MO

Senior Systems Engineer

Olathe, KS · On-site

$98K - $135K/yr

Participate in risk management activities, design reviews, and phase gate reviews to ensure product ... medical device development under quality systems * Experience with Source Code Management ...

... manage risk, and tackle complex integration challenges to deliver life‑changing medical and ... Experience interpreting and applying medical device standards such as ISO 60601-1, ISO 13485 etc ...

... manage risk, and tackle complex integration challenges to deliver life-changing medical and high ... Experience interpreting and applying medical device standards such as ISO 60601-1, ISO 13485 etc ...

Required * 5+ years of catastrophe modeling experience or risk management * Expertise with third ... Medical, dental, vision, life, disability, HSA, FSA * Retirement : 401(k) * Perks : Free snacks ...

Required * 5+ years of catastrophe modeling experience or risk management * Expertise with third ... Medical, dental, vision, life, disability, HSA, FSA * Retirement : 401(k) * Perks : Free snacks ...

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Medical Device Risk Management information

See Lees Summit, MO salary details

$50.1K

$108.5K

$165.4K

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

As of Aug 9, 2026, the average yearly pay for medical device risk management in Lees Summit, MO is $108,542.00, according to ZipRecruiter salary data. Most workers in this role earn between $87,600.00 and $125,500.00 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.

Full-time

Re-posted 2 days ago


Job description

Primary Purpose: To identify, assess, and mitigate organizational risks to ensure patient, staff and visitor safety, protect assets, and maintain regulatory compliance. Conduct risk assessments, ensure compliance with legal and regulatory requirements, and manage incidents to minimize liabilities and hazards. The goal is to create a safe working environment while reducing potential losses or disruptions due to accidents, unsafe practices, or unforeseen risks.

Reports to:  Director, Quality and Safety

Formal Policy—Setting Responsibilities: Formally responsible for facilitating policy and practice associated with the job’s purpose and essential responsibilities.

Routine Decision Making: In coordination with others, develops and implements, plans and monitors compliance with established priorities and objectives.

Formal Supervisory Responsibilities: Formal supervisory responsibility:  Facilitates committees and influencing department managers. No direct reports. 

Unusual Working Conditions: Risk of blood/body fluid contamination. Potential exposure to hazardous drugs and chemicals.

Age Specific Competencies: None required.

ESSENTIAL RESPONSIBILITIES AND TASKS

Manages and oversees Cass Regional’s Risk Management Program. (50% of time)

  • Participates in medical malpractice and general liability claims management process including working with liability carrier to secure necessary documents
  • Collaborates with and assists organizational leadership, management, physicians and staff to help implement, monitor and evaluate Cass Regional Medical Center’s Risk Management Plan
  • Identify risks to the Medical Center by performing risk assessments, review past incidents and claims, hospital loss and liability reports, and local and national hospital-related incident or risk data and statistics
  • Provides education to hospital staff related to opportunities for improvement in collaboration with department leadership members
  • Reviews attorney requested charges from a Risk Management perspective
  • Coordinates with Healthcare Services Group (HSG) in collaboration in the Quality and Safety Director for any pending cases
  • Supports the Medical Staff Quality Assurance program
  • Attends and participates in Cass Regional Medical Center Regulatory Compliance meetings as needed
  • Manages the day-today operations of the organization’s patient concern process/system.  Logs, tracks, trends and reports data collected within system.  Addresses concerns on an individual case-by-case basis and follows up to resolution
  • Works closely with Director, Quality and Safety related to patient concerns that involve quality of care concerns and issues
  • Evaluates, manages, and oversees the procurement and annual renewal of the Medical Center’s insurance programs, including general and professional liability, medical liability, property and contents (with business income protection), Directors & Officers, employee practices, cyber liability, boiler and machinery, crime, and commercial automobile coverage. Recommends adjustments as needed to ensure appropriate, comprehensive, and cost-effective protection of Medical Center assets and operations.
  • Develops risk management training programs and presents directly to or secures training of staff, management, leadership, medical staff and the Board of Trustees about risk issues, which may involve collaborative efforts with unit leadership members
  • Reports identified patient risk issues to the PSO
  • Leads Root Cause Analysis for Serious Safety Events and Sentinel Events

Supports Cass Regional’s efforts related to compliance with the Joint Commission, Center for Medicare and Medicaid Conditions of Participation and Department of Health and Senior Services and other accreditation/licensure bodies and their regulations/standards as it relates to Risk Management. (15% of time)

  • Serves as Section 1557 Coordinator, ensuring compliance with nondiscrimination requirements including grievance handling, recordkeeping, and language access.
  • Serves as the Civil Rights Coordinator, ensuring compliance with nondiscrimination requirements including grievance handling, recordkeeping, and language access.

Recommends new procedures and approaches to loss prevention based on reports of incidents, accidents, and other events.  (25% of time)

  • Review all employee injury reports and suggest adaptations or conformity to safety precautions.  Works in conjunction with Human Resources Compensation Program and Infection Prevention Coordinator and Employee Health Specialist
  • Responsible for facilitating the ongoing transition from a retrospective, reactive model for risk management to a prospective, proactive loss prevention program  
  • Participates in EOC/Safety Committee meetings monthly. Report out incident report data monthly.
  • Ensures annual Ligature Risk Assessment for organization is completed and reported to EOC/Safety Committee.
  • Leads meeting Falls Committee. Falls Committee meets monthly, and more frequently as deemed appropriate. 
  • Responsible for the Medical Center’s Event Reporting process including summarizing and trending of reports submitted, analyzing for trends, recommending changes to reduce trends and reporting monthly and annually to the Board of Trustees.
  • Investigates any incidents that may result in visitor, staff, physician injury, property damage and asset loss.
  • Evaluates all compensable events, claims and lawsuits for underlying issues and identifies opportunities for improvement and addresses lessons learned

ESSENTIAL PHYSICAL REQUIREMENTS 

  • Sedentary Work:  Lifting 10# maximum and occasionally lifting and/or carrying such articles as dockets, ledgers and small tools.  Jobs are sedentary:  if walking and standing are required only occasionally.

PHYSICAL DEMANDS 

  • Lifting:  Raising or lowering an object from one level to another (includes upward pulling).
  • Carrying:  Transporting an object, usually holding it in hands or arms or on the shoulders.
  • Pushing:  Exerting force upon an object so that the object moves away from the force (including slapping, striking, kicking, and treadle actions).
  • Pulling:  Exerting force upon an object so that the object moves toward the force (includes jerking).
  • Climbing:  Ascending or descending ladders, stairs, scaffolding, ramps, poles, ropes and the like, using the feet and the legs and/or hands and arms.
  • Hearing:  Ability to determine audible communication.
  • Stooping:  Bending the body downward and forward by bending the spine at the waist.
  • Reaching:  Extending the hands and arms in any direction.
  • Handling:  Seizing, holding, grasping, turning or otherwise working with the hand or hands (fingering not involved).
  • Fingering:  Picking, pinching, or otherwise working with the fingers primarily (rather than the whole hand or arms as in handling).
  • Repetitive Motions:  Substantial movements (motions) of the wrist, hands, and/or fingers.
  • Feeling:  Perceiving such attributes of objects and materials as size, shape, temperature, or texture by means of receptors in the skin, particularly those of the fingertips.
  • Speaking:  Expressing or exchanging ideas by means of the spoken word.  Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly or quickly.
  • Seeing:  Obtaining impressions through the eyes of the shape, size, distance, motion, color or other characteristics of objects.
  • Acuity, far – clarify of vision at 20 feet or more.
  • Acuity, near – clarity of vision of 20 inches or less.
  • Depth perception – ability to judge distance and space relationships so as to see objects where and as they actually are.
  • Field of vision – area seen up and down or to the right or left while eyes are fixed.
  • Accommodations – adjustment of the lens of the eye to bring an object into sharp focus.
  • Color vision – the ability to identify and distinguish colors.

WORKING CONDITIONS

  • Inside:  Worker spends approximately 75% or more of time inside.

Education and Certification/Registration Required for the Position: Bachelor’s degree in nursing, risk management, or related field required; Master’s preferred.  CPHRM, CHSP, or other risk/safety-related certification preferred. Current licensure as a Registered Nurse (RN) in the state of Missouri or compact state required. 3-5 years of management experience, including 2-3 years in risk management preferred.

Required Knowledge: Functions of goal setting processes; HIPAA regulations; knowledge of healthcare risk reduction strategies, general knowledge of regulatory requirements on the state and federal level, patient safety principles, risk financing/insurance programs, claims management.

Required Skills and Abilities: Ability to lead investigations and root cause analyses, facilitate safety culture, and influence change across departments.