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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 ... Participate in design and process risk management activities (e.g., FMEA, material risk assessments)

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)

Senior Process Engineer

Huntersville, NC

$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 ...

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 ...

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 ...

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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 Jul 26, 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.

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

Associate Medical Device Sales Representative

Medical Sales College

Gastonia, NC • On-site

Other

Medical, Dental, Vision, Retirement, PTO

Posted 3 days ago


Job description

Job Title: Associate Medical Device Sales Representative Location: Multiple Territories Nationwide (Field-Based / Territory-Based) Position Type: Full-Time What a Medical Device Sales Representative Does Beginning a career in medical device sales as an associate medical device sales representative is a unique, high-impact fusion of elite business-to-business sales and direct clinical consultancy. Medical device representatives do not simply drop off products; they act as vital clinical advisors to healthcare providers. In this role, as an associate medical device sales representative, you will be trained to master a complex portfolio of medical technology or diagnostic solutions. You will work closely with surgeons, physicians, and clinic directors—often standing alongside them in active operating rooms, clinical clinics, or diagnostic offices—to provide critical technical execution, instruction, and safe product utilization. Your day-to-day work is directly tied to improving patient mobility, advancing clinical outcomes, and bringing disruptive technologies to the medical community. About the Premier Industry Partner Pathway Because of the highly technical, high-stakes nature of the medical environment, corporate device manufacturers cannot risk placing untrained personnel into a clinic or a live operating room. Consequently, breaking into this exclusive industry without a mixed background in medical sales is notoriously difficult. To bridge this gap, we recruit directly on behalf of our Premier Industry Partner hiring managers to identify and develop top-tier talent. As a mandatory evaluation and preparation baseline for candidates who do not possess a strong combination of direct medical sales and clinical field experience, select applicants are required to successfully complete specialized on-campus training through Medical Sales College (MSC) / Med Sales Institute (MSI). Much like the specialized technical certifications and self-funded training tracks required to enter fields like veterinary technology or nursing, this program requires a personal tuition investment from the candidate (with financing options and flexible payment plans available for qualified applicants). Investing in this specialized preparation is the single most effective way to set yourself up for long-term success in the medical device industry. This universally recognized curriculum provides the exact real-world clinical, surgical, and commercial skills required to step into a territory and perform immediately. Its track record is proven: Medical Sales College has helped over 5,000 graduates secure placements in the medical sales industry. During and upon completion of the training, candidates undergo structured evaluations, jointly conducted by Medical Sales College and our corporate hiring teams, for direct placement. Scholarships are available for top-qualified candidates. Our Premier Corporate & Laboratory Partners Include: Stryker / CrossLink: Market leaders in advanced orthopedic reconstruction, trauma systems, and cutting-edge surgical platforms (including the Mako Robotic System). Medacta USA: A global innovator pioneering anterior minimally invasive hip surgery, specialized joint reconstructions, and augmented reality surgical technologies. Icarus Medical: A high-growth med-tech company disrupting the orthopedic sector with patented, advanced custom bracing software and additive manufacturing (DME). TEN Healthcare: A rapidly growing diagnostic laboratory business delivering premier molecular PCR infectious disease, blood, and toxicology solutions directly to independent clinics. Pristine Surgical: A disruptive medical technology company introducing single-use digital endoscopy platforms to eliminate the complexities of traditional visualization systems in ambulatory surgery centers. Key Responsibilities & What You Will Do Clinical, Technical & Software Support: Serve as a front-line technical expert during live procedures or medical consultations. Guide surgeons, clinicians, and nurses on product mechanics, technical specifications, and proprietary planning software. B2B Territory Prospecting & Market Share Growth: Identify, map, and aggressively prospect competitive accounts within your territory. Execute cold calls and in-person outreach to independent clinics, hospitals, and surgical centers. Educational In-Services: Conduct formal product demonstrations, coordinate hands-on sawbones labs, and host clinical "in-service" training sessions to drive product adoption. Logistics & Inventory Management: Oversee the flawless coordination of surgical trays, technical implants, capital equipment, or laboratory diagnostic kits to ensure seamless account operations. Cross-Department Collaboration: Partner with internal corporate teams across engineering, manufacturing, and billing to facilitate smooth client onboarding and support new product launches. Who We Are Looking For (Candidate Profile) High Sales DNA & Grit: Competitively minded individuals who possess a relentless work ethic and thrive when held to high performance metrics. Adaptability in High-Pressure Settings: Professionals who are energized by fast-paced, complex environments (such as a sterile operating room or busy clinic) and can solve technical issues seamlessly under pressure. Technical Aptitude: Fast learners who are excited to digest intricate anatomical frameworks, biological data, and biomechanical functionalities. Diverse Professional Archetypes: This pathway highly values driven B2B sales professionals (e.g., copier, payroll, or uniform sales), former collegiate/professional athletes, military veterans, and clinical staff (e.g., nurses, PTs, EMTs) looking to pivot into the commercial sector. Position Requirements Education: Bachelor’s degree preferred, or an equivalent level of professional commercial experience. Recent graduates are preferred to have a cumulative GPA of 3.2 or higher. Pathway Requirement: Successful completion of the required Medical Sales College program (such as TotalOrtho, TotalOrtho+, or specialized diagnostic/orthopedic tracks) serves as the prerequisite industry baseline for candidates lacking direct field experience. Financial Commitment: The ability to fund the program tuition required for this career transition training (financing and flexible payment options are available to assist qualified applicants). Compliance & Credentialing: Must have the ability to attain strict hospital vendor credentials, including up-to-date health screenings, vaccinations, and background checks. Mobility: Must possess a valid driver’s license and the ability to travel up to 50% locally within your designated territory. Ability to routinely lift and transport up to 40 lbs of technical instrumentation or medical kits. Schedule Flexibility: Depending on the explicit partner assignment (especially within Orthopedic Trauma), candidates must be highly reliable and accessible for routine overnight, weekend, or holiday call rotations. What is Offered A Highly Financially Rewarding Career: Competitive base salary structures coupled with performance bonuses and uncapped corporate commission models. Elite Corporate Benefits: Access to comprehensive healthcare (medical, dental, vision), paid time off, 401(k) matching programs, and corporate vehicle allowances or mileage reimbursement. Clear Upward Mobility: A direct, structured professional pipeline from an Associate role into full Territory Management. How to Apply Click "Apply Now" to submit your resume for review. Selected candidates will be invited to an initial screening with an MSC Admissions Recruiter to assess your aptitude for sales, discuss your career goals, review tuition investment/financing options, and coordinate placement pipelines with our premier industry partners.