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Medical Device Risk Management Jobs in Fort Mill, SC

We are seeking a Medical Device Engineer with developing to advanced expertise in expanded PTFE ... risk management activities (e.g., FMEA, material risk assessments) Ensure design controls and ...

General Manager

Charlotte, NC · On-site

$175K - $220K/yr

... and risk management. Customer and Commercial Partnership * Build and maintain executive-level relationships with strategic customers within the interventional medical device market. * Serve as the ...

New

We are seeking a Medical Device Engineer with developing to advanced expertise in expanded PTFE ... Participate in design and process risk management activities (e.g., FMEA, material risk assessments)

Quality Engineer II

Huntersville, NC · On-site

$67K - $87K/yr

Technical knowledge and understanding of the medical device industry. Must have experience in risk identification, mitigation, and risk management Prior Supervisory experience is preferred Experience ...

Quality Engineer II

Huntersville, NC

$67K - $87K/yr

Technical knowledge and understanding of the medical device industry. Must have experience in risk identification, mitigation, and risk management Prior Supervisory experience is preferred Experience ...

Quality Engineer II

Huntersville, NC · On-site

$67K - $87K/yr

Technical knowledge and understanding of the medical device industry. Must have experience in risk identification, mitigation, and risk management Prior Supervisory experience is preferred Experience ...

Senior Process Engineer

Huntersville, NC · On-site

$97K - $126K/yr

... of medical device product(s) including determination of process flow, fixture/tooling development ... related risk management activities including process FMEAs, as well as support application and ...

... risk management, ISO 14971, ISO 13485, and 21 CFR Part 820 Familiarity with applicable medical device standards including ISO 10555, ISO 11070, ISO 5840, ISO 25539, and related standards Strong ...

Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR Part 820 * Familiarity with applicable medical device standards including ISO 10555, ISO 11070, ISO 5840, ISO ...

Senior Process Engineer

Huntersville, NC · On-site

$97K - $126K/yr

... of medical device product(s) including determination of process flow, fixture/tooling development ... related risk management activities including process FMEAs, as well as support application and ...

Senior Process Engineer

Huntersville, NC · On-site

$97K - $126K/yr

... of medical device product(s) including determination of process flow, fixture/tooling development ... related risk management activities including process FMEAs, as well as support application and ...

... of medical device product(s) including determination of process flow, fixture/tooling development ... Lead process-related risk management activities including process FMEAs, as well as support ...

... and medical providers, and maintaining documentation to support effective claim management ... of Risk Management of any concerns. Conducts annual MVR audits and oversees tracking of personal ...

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Showing results 1-20

Medical Device Risk Management information

See Fort Mill, SC salary details

$45.3K

$98K

$149.4K

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

As of Aug 18, 2026, the average yearly pay for medical device risk management in Fort Mill, SC is $98,030.00, according to ZipRecruiter salary data. Most workers in this role earn between $79,100.00 and $113,400.00 per year, depending on experience, location, and employer.

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 are popular job titles related to Medical Device Risk Management jobs in Fort Mill, SC?

For Medical Device Risk Management jobs in Fort Mill, SC, the most frequently searched job titles are:

Territory Manager- Medical Device Sales (REMOTE)

Pulm-One

Charlotte, NC

$85K/yr

Full-time

Re-posted 5 days ago


Job description

Territory Manager – Pulmonary Function Testing (Medical Device)

Territory: Georgia / South Carolina / North Carolina
Company: PulmOne
Reports To: Vice President of Sales

Compensation: Base Salary: $85,000 + Uncapped Commission

Work Arrangement: Remote (Field-Based Territory Sales)

Schedule: Full-time, Monday–Friday, 40–60 hours per week

About the Opportunity

PulmOne is a fast-growing medical device company transforming the way pulmonary function testing (PFT) is performed. Our innovative MiniBox+ delivers true plethysmography and full diagnostic pulmonary function testing in a compact, fully portable system, allowing physician practices, hospitals, and PFT labs to provide gold-standard lung testing directly in their offices.

We are seeking a motivated and relationship-driven Territory Manager to grow our Georgia, South Carolina, and North Carolina territory. This is an excellent opportunity for a successful medical sales professional who enjoys building relationships, managing a territory independently, and selling innovative technology that improves patient care.

Territory

The ideal candidate will reside in one of the following locations:

  • Charlotte, NC
  • Greenville, SC
  • Atlanta, GA

This territory includes:

  • Atlanta, GA
  • Augusta, GA
  • North Georgia
  • South Carolina
  • North Carolina

This is a field-based remote position requiring regular travel throughout the assigned territory, including occasional overnight travel.

What You'll Do
  • Own your assigned territory from prospecting through post-sale account growth.
  • Build and maintain a healthy sales pipeline by identifying and developing new business opportunities.
  • Sell the MiniBox+ capital system along with recurring disposable products that generate ongoing revenue.
  • Conduct in-person product demonstrations for physicians, office managers, and healthcare staff.
  • Educate customers on the clinical, operational, reimbursement, and financial value of the MiniBox+ system.
  • Build long-term relationships with physicians, healthcare administrators, and key decision-makers.
  • Partner with clinical and customer success teams to ensure successful installations, product training, and customer satisfaction.
  • Maintain accurate customer activity, forecasts, and pipeline information within Salesforce.
  • Represent PulmOne at regional and national conferences, including CHEST, ATS, ACAAI, ACR, and other industry events.
Who You'll Call On

You'll build relationships with healthcare providers including:

  • Pulmonologists
  • Allergists/Immunologists
  • Primary Care Physicians
  • ENTs (Otolaryngology)
  • Cardiologists
  • Rheumatologists
Sites of Service

You'll sell across a variety of healthcare settings, including:

  • Independent and private physician offices
  • Hospital Outpatient Departments (HOPDs)
  • Integrated Delivery Networks (IDNs)
  • Health systems
Qualifications
  • Bachelor's degree required.
  • Minimum of 3 years of B2B sales experience.
  • Medical device, diagnostic, or capital equipment sales experience strongly preferred.
  • Proven track record of meeting or exceeding sales quotas.
  • Experience presenting and selling clinical products to physicians or healthcare providers.
  • Strong prospecting, presentation, communication, and relationship-building skills.
  • Ability to explain both the clinical and business value of a product, including reimbursement and return on investment.
  • Self-motivated with the ability to independently manage a large geographic territory.
  • Experience using Salesforce or another CRM platform.
  • Willingness to travel extensively throughout the assigned territory, including occasional overnight travel.
  • Valid driver's license with a clean driving record.
Preferred Qualifications
  • Experience selling capital medical equipment.
  • Experience with diagnostic or respiratory products.
  • Knowledge of healthcare reimbursement, compliance, and clinical workflows.
  • Experience conducting live product demonstrations and supporting pre-sales activities.
Why Join PulmOne?
  • Competitive base salary of $85,000 plus an uncapped commission plan.
  • Remote, field-based position with the flexibility to manage your own territory.
  • Opportunity to sell an innovative product in a large, underpenetrated market.
  • Comprehensive onboarding, product training, and ongoing clinical support.
  • Collaborative team environment with direct access to company leadership.
  • Career growth opportunities with an expanding medical device company.

If you're a driven sales professional who enjoys building relationships, developing new business, and helping healthcare providers improve patient care through innovative technology, we'd love to hear from you. Apply today to join the PulmOne team!


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