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Medical Device Risk Management Jobs in Gainesville, GA

Theragenics Corp

Project Manager

Buford, GA · On-site

Develop and manage comprehensive project plans, schedules, resource allocations, and risk ... within PMO environments. * Technical background with a solid understanding of medical device ...

LanceSoft Inc

Supplier Quality Manager

Athens, GA

... Medical Device industries. We understand the clinical trial process from Phase I through Phase IV. ... Complete Supplier data for metrics and risk management documents. Manage low risk (low criticality ...

Theragenics Corp

Project Manager

Buford, GA · On-site

Develop and manage comprehensive project plans, schedules, resource allocations, and risk ... within PMO environments. * Technical background with a solid understanding of medical device ...

Spectrum Plastics Group

Product Manager

Alpharetta, GA · On-site

Master's degree preferred. * 5+ years of product management experience in the medical device industry, ideally in cardiovascular or catheter-based solutions. * Proven experience in a CDMO environment ...

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Medical Device Risk Management information

See Gainesville, GA salary details

$48K

$104K

$158.5K

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

As of Sep 12, 2026, the average yearly pay for medical device risk management in Gainesville, GA is $104,021.00, according to ZipRecruiter salary data. Most workers in this role earn between $83,900.00 and $120,300.00 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 job categories do people searching Medical Device Risk Management jobs in Gainesville, GA look for?

The top searched job categories for Medical Device Risk Management jobs in Gainesville, GA are:

What cities near Gainesville, GA are hiring for Medical Device Risk Management jobs?

Cities near Gainesville, GA with the most Medical Device Risk Management job openings:

Medical Device Risk Management jobs near you

Medical Devices Industry Solution Manager

Alpharetta, GA • On-site

Siemens AG
See more jobs at Siemens AGexternal

Other

Posted 11 days ago

Key responsibilities

  • Define and develop Medical Devices solutions that span the full Digital Industry portfolio, focusing on engineering, manufacturing software, automation, and systems.

  • Support the Medical Devices industry go-to-market efforts through solution campaigns, field enablement, and engagement with sales and strategic customers.

  • Collaborate with industry partners and internal teams to establish market applicability, develop industry strategy, and support solution messaging and value propositions.

Job description

Job Family: Software

Req ID: 510845

Job Description

As a member of the Life Sciences Industry team focusing on Medical Devices Segment, the solution manager is a senior, experienced global technology and business leader who applies deep industry technology, domain knowledge and best practices to contribute individually and collaborate with global teams of technical product and business development leaders, from Sales and Services to Software, Product Development and Marketing.

We are seeking individuals who possess extensive experience in medical devices industry, through the entire life cycle, from engineering through manufacturing and service and possess specific expertise in developing and applying Siemens Digital Industries Software portfolios

Build the future direction of Medical Devices by leading initiatives focused on identifying, scoping and then support developing winning solutions for the Medical Devices industry.

  • Define unique, differentiated Medical Devices solutions that span the full Digital Industry portfolio with a focus on combining engineering and manufacturing software with automation and systems, involving subject matter experts from the field and relevant business segments

  • Establish market applicability and firm financial foundation for unmet solution needs based on best-in-class industry process context and business value justification

  • Collaborate with selected external solution partners to extend Medical Devices Digital Industry solution capabilities

Support the Medical Devices industry go-to-market through industry solution campaigns and field enablement in high priority areas

  • Support definition of Medical Devices solution messaging and value propositions

  • Collaborate with Industry vertical and Business Unit marketing teams to enable them to create compelling internally and externally facing campaign materials

Engage and enable Sales and Strategic Customers

  • Support industry solution go-to-market enablement for sales organizations

  • Engage with strategic customers to understand solution requirements

  • Support sale of strategic Medical Devices Digital Industry solutions

Support Industry Leaders in developing/updating the global Medical Devices industry strategy by contributing your industry knowledge and expertise.

Prerequisites & Essential Functions

Qualifications include:

  • Engineering degree - Mechanical, Electrical, Systems, Software, Manufacturing Operations Management, or equivalent

  • Detailed knowledge of Medical Devices business methods, processes, and practices, with excellent verbal, written, and presentation communication skills.

  • 10+ years of experience in the Medical Devices industry and/or providing PLM solutions to the medical device industry customers.

  • Experience working in multi-disciplinary engineering and manufacturing teams, in one or more of the following areas is highly desirable: Design and Engineering, Regulatory Compliance to Medical Device Regulatory standards in areas such as Quality/QMS, Design Controls, Document and Record Controls, CAPA etc, Manufacturing, Service & Support, Lifecycle Management and/or Industrial IOT implementation and/or providing PLM solutions to the medical device industry customers.

  • Direct, practical experience with several of the following software technology categories corresponding to Siemens DI SW portfolio: MCAD, ECAD, CAE, PLM, ALM, Manufacturing Engineering, CAM, Manufacturing Operations Management (MES), Service Lifecycle Management, Software, DevOps or Industrial IOT. Working knowledge and practical application of our products and solutions in compliance with international medical device regulations.

  • Salary range posted is for hires based in the United States of America only.

Qualified Applicants must be legally authorized for employment in the United States. Qualified Applicants will not require employer sponsored work authorization now or in the future for employment in the United States.

Work Conditions / Physical Requirements

  • Normal office environment. Can work from home, within a 2-hour drive to a regional airport or work from a local office if located in most major cities

  • Preferred location for this role is in the United States of America, but candidates based anywhere in the world where DISW has a legal entity may be considered

  • This is a global role, and it is expected that the candidate has appropriate freedom to travel in accordance with aforementioned responsibilities

154,200 277,600 10%

Organization: Digital Industries

Job Type: Full-time

Category: Research & Development

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