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Medical Device Risk Management Jobs in Missouri (NOW HIRING)

kindeva

Senior Device Engineer

Maryland Heights, MO

$101K - $138K/yr

Develops Design History File documents, Risk Management documents, change management technical ... Experience in Medical Device or Combination Products Design Controls, Production, Sustaining ...

kindeva

Senior Device Engineer

Maryland Heights, MO

$101K - $138K/yr

Develops Design History File documents, Risk Management documents, change management technical ... Experience in Medical Device or Combination Products Design Controls, Production, Sustaining ...

kindeva

Senior Device Engineer

Maryland Heights, MO · On-site

$101K - $138K/yr

Develops Design History File documents, Risk Management documents, change management technical ... Experience in Medical Device or Combination Products Design Controls, Production, Sustaining ...

kindeva

Senior Device Engineer

Maryland Heights, MO

$101K - $138K/yr

Develops Design History File documents, Risk Management documents, change management technical ... Experience in Medical Device or Combination Products Design Controls, Production, Sustaining ...

ArchKey Solutions

Risk Management Specialist

Fenton, MO · On-site

RISK MANAGEMENT SPECIALIST This position is based out of our St Louis, MO office About the company ... medical, dental, and vision), a robust 401(k) retirement savings plan with employer match, paid ...

ArchKey Solutions

Risk Management Specialist

Fenton, MO · On-site

RISK MANAGEMENT SPECIALIST This position is based out of our St Louis, MO office About the company ... medical, dental, and vision), a robust 401(k) retirement savings plan with employer match, paid ...

Astellas

The Risk Management Officer partners with Medical Safety, Epidemiology, Signal Management Officers, and other functions within the Safety Sciences and Labeling group, as well as Regulatory Leads, the ...

MasterCard

Manager, Risk Management

O Fallon, MO · On-site +1

... Risk Management Overview The Manager, Internal Controls, will take a key role in our SOX Compliance ... Do not include any medical or health information in this email. The Reasonable Accommodations team ...

Mastercard, Inc.

Manager, Risk Management

O Fallon, MO · On-site

... Risk Management Overview The Manager, Internal Controls, will take a key role in our SOX Compliance ... Do not include any medical or health information in this email. The Reasonable Accommodations team ...

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Medical Device Risk Management information

See Missouri salary details

$48.3K

$104.6K

$159.5K

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

As of Jun 6, 2026, the average yearly pay for medical device risk management in Missouri is $104,640.00, according to ZipRecruiter salary data. Most workers in this role earn between $84,400.00 and $121,000.00 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 are popular job titles related to Medical Device Risk Management jobs in Missouri? For Medical Device Risk Management jobs in Missouri, the most frequently searched job titles are:
What job categories do people searching Medical Device Risk Management jobs in Missouri look for? The top searched job categories for Medical Device Risk Management jobs in Missouri are:
What cities in Missouri are hiring for Medical Device Risk Management jobs? Cities in Missouri with the most Medical Device Risk Management job openings:
Medical Device Risk Management jobs near you
Senior Device Engineer

Senior Device Engineer

Kindeva Drug Delivery

Maryland Heights, MO • On-site

$101K - $138K/yr

Full-time

Posted 19 days ago

Job description

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
Works as a device engineering team lead or member/lead of cross-functional teams, as well as independent contributor throughout the Combination Product Life Cycle process. Leads or participates in cross-functional teams for design changes, design transfer activities, continuous improvement projects, investigations, risk assessments and protocol execution. Responsible for device life cycle management of on-market combination products and implementation of new products. Develops Design History File documents, Risk Management documents, change management technical impact assessments, test plans/ protocols, test method validations, and data analysis. Leads design changes from initiation through design transfer. Performs or oversees engineering, design, and development work. Develops design concepts/ideas for product improvements, fixtures, gages, and test methods. Develops prototypes of design concepts for engineering testing and evaluation. Generates or reviews/approves SOPs, test protocols, engineering test reports and provides laboratory oversight as needed. Responsible for adhering to design controls and documenting all product development work and updates in a Design History File.
Role Responsibilities
  • Leads or participates in design control, change management and risk management activities related to the combination device, design and manufacturing process ensuring compliance to all applicable regulations including FDA Regulation and Guidance for Combination Products
  • Perform Quality Risk Assessments
  • Performs or oversees biomedical/mechanical engineering design and development work, including design changes and product improvements, Geometric Design and Tolerancing, drawings, tolerance stacks, risk analyses, and engineering analyses. Establishes or reviews/approves specifications and inspection requirements for components, products, and processes.
  • Develops prototypes of design concepts for engineering testing and evaluation
  • Creates or reviews/ approves SOPs, Job Aids, test protocols, reports and risk-based plans for verification and validation testing.
  • Develops/ approves/ maintains DHF documents and rationales in support of design changes, design transfer, investigations, information requests, and product life cycle
  • Supports Manufacturing, QCD Lab, QDS Lab, Quality Engineering, and Quality Assurance with investigations and the qualification of new material/ processes/ equipment to assure reliability requirements are met. Participates in or leads CAPA investigations.
  • Provides input and technical support for device changes, document updates, process changes, risk management. Performs assessments for change control and may represent group and product on change control review committee. Accountable for change management projects or investigation actions related to the device, design, manufacturing process, or new/updated standards and regulations.
  • Develops test methods, fixtures, gages, challenge samples, limit samples, simulation devices, and engineering prototypes of design concepts
  • Develops or collaborates on and adheres to project plans, timelines, and budgets
  • Liaison with internal production sites, quality, regulatory R&D, and Tech Transfer/Launch Teams
  • Establish and maintain relationships with production sites and key stakeholders
  • Technical oversight of other engineers
  • May require management of cross-functional teams and indirect reports
  • Reports and escalates to leadership as appropriate
  • May provide training for new hires or contractors and may oversee work conducted by contractors or lab technicians.
  • Other duties as assigned

Basic Qualifications
  • Experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering role or related field
  • B.S. Degree in Engineering discipline with 7 - 9 years experience
  • M.S. Degree in Engineering discipline with 5 - 7 years experience
  • Ph.D. in Engineering discipline with 3 - 5 years experience
  • (Biomedical Engineering or Mechanical Engineering preferred)

Preferred Qualifications
  • Thorough understanding and in-depth knowledge of FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30, ISO 13485 and ISO 14971 and related standards, and EU Medical Device Directives
  • Understanding of production and production systems in a GMP regulated environment
  • Strong technical project management, critical thinking, and problem-solving skills. Proficient in Smartsheet or MS Project.
  • Experience analyzing complex issues for patient/user impact
  • Understanding of Human factors and usability engineering
  • Conceptual design skills and experience with a variety of manufacturing methods (e.g. injection molding, machining, etc.)
  • Proficiency in SolidWorks design software, Mathcad, MindManager, and other general computer software such as word processing, spreadsheets, presentations, flow charts, etc. Strong laboratory skills such as component inspection or failure analysis, mechanical testing, etc. with a good understanding of GMP documentation and data integrity requirements.
  • Strong mathematical, analytical, and reasoning skills
  • Strong innovation skills and creativity astuteness
  • Strong teamwork and organizational skills
  • Strong written and oral communication
  • Knowledge of Design for Reliability and Manufacturing (DRM) and robust device design practices
  • Ability to prioritize multiple responsibilities and to work on multiple complex technical projects simultaneously
  • Experience with FDA investigators and other global regulatory agencies in the front room or providing back room support

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California residents should review our Notice for California Employees and Applicants before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees-regardless of format-without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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