With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious ...
With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious ...
Embedded Firmware Engineer
Ball Ground, GA · On-site
$96K - $131K/yr
Firmware design, testing, debugging, and documentation, including sequence diagrams, system ... Familiarity with the Medical Device Directive/Regulation (MDD/MDR), ISO 13485, FDA design controls ...
Quick apply
Embedded Firmware Engineer
Ball Ground, GA · On-site
$96K - $131K/yr
Firmware design, testing, debugging, and documentation, including sequence diagrams, system ... Familiarity with the Medical Device Directive/Regulation (MDD/MDR), ISO 13485, FDA design controls ...
Embedded Firmware Engineer
$96K - $131K/yr
... the Medical Device Directive/Regulation (MDD/MDR), ISO 13485, FDA design controls or similar ... testing, CI/CD, BDD and TDD Building hardware/software integrated test jigs a plus *Qt/Qml ...
Embedded Firmware Engineer
$96K - $131K/yr
... the Medical Device Directive/Regulation (MDD/MDR), ISO 13485, FDA design controls or similar ... testing, CI/CD, BDD and TDD Building hardware/software integrated test jigs a plus *Qt/Qml ...
With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious ...
With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious ...
With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious ...
Quick apply
With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious ...
Embedded Firmware Engineer
Ball Ground, GA · On-site
$96K - $131K/yr
Firmware design, testing, debugging, and documentation, including sequence diagrams, system ... Familiarity with the Medical Device Directive/Regulation (MDD/MDR), ISO 13485, FDA design controls ...
Embedded Firmware Engineer
Ball Ground, GA · On-site
$96K - $131K/yr
Firmware design, testing, debugging, and documentation, including sequence diagrams, system ... Familiarity with the Medical Device Directive/Regulation (MDD/MDR), ISO 13485, FDA design controls ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
Quick apply
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
Perform API security testing, traffic interception, and replay analysis using tools such as Burp ... Experience with IoT, embedded systems, or connected devices (medical device experience a strong ...
Perform API security testing, traffic interception, and replay analysis using tools such as Burp ... Experience with IoT, embedded systems, or connected devices (medical device experience a strong ...
Software QA Engineer 1
Berkeley Lake, GA · On-site
... testing, traffic interception, and replay analysis using tools such as Burp Suite or Fiddler ... medical device design controls is a plus)
Software QA Engineer 1
Berkeley Lake, GA · On-site
... testing, traffic interception, and replay analysis using tools such as Burp Suite or Fiddler ... medical device design controls is a plus)
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
Quick apply
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
Avanos is a medical device company focused on delivering clinically superior breakthrough solutions ... testing and test method development, and creating prototypes. * Apply sound engineering principles ...
Avanos is a medical device company focused on delivering clinically superior breakthrough solutions ... testing and test method development, and creating prototypes. * Apply sound engineering principles ...
Avanos is a medical device company focused on delivering clinically superior breakthrough solutions ... testing and test method development, and creating prototypes. * Apply sound engineering principles ...
Avanos is a medical device company focused on delivering clinically superior breakthrough solutions ... testing and test method development, and creating prototypes. * Apply sound engineering principles ...
Quality Manager
Atlanta, GA · On-site
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
Quick apply
Quality Manager
Atlanta, GA · On-site
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
Quality Manager
Atlanta, GA · On-site
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
Quality Manager
Atlanta, GA · On-site
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
Quality Manager
Atlanta, GA · On-site
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
Quality Manager
Atlanta, GA · On-site
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of ...
Medical Device Testing information
See Atlanta, GA salary details
$22.85 is the 25th percentile. Wages below this are outliers.
$20.57 - $24.88
47% of jobs
The median wage is $26.08 / hr.
$24.88 - $29.19
9% of jobs
$29.19 - $33.50
0% of jobs
$33.50 - $37.81
4% of jobs
$41.37 is the 75th percentile. Wages above this are outliers.
$37.81 - $42.11
17% of jobs
$42.11 - $46.42
8% of jobs
$46.42 - $50.73
7% of jobs
$50.73 - $55.04
4% of jobs
$55.04 - $59.35
0% of jobs
$59.35 - $63.66
0% of jobs
$63.66 - $67.96
2% of jobs
$20
$35
$67
How much do medical device testing jobs pay per hour?
What are the key skills and qualifications needed for medical device testing?
To thrive in Medical Device Testing, you need a strong background in biomedical engineering, quality assurance, and regulatory compliance, often supported by a relevant degree. Hands-on experience with testing equipment, validation protocols, and familiarity with standards such as ISO 13485 and FDA guidelines are typically required. Attention to detail, analytical thinking, and clear documentation skills are essential soft skills for excelling in this field. These abilities ensure that devices meet safety and performance standards, protecting patient health and supporting company compliance.
What does medical device testing involve?
Professionals in Medical Device Testing typically spend their days conducting tests on new or existing medical devices to ensure they meet quality, safety, and regulatory standards. This often involves following strict protocols, documenting results accurately, and troubleshooting any performance or compliance issues that arise. Team members frequently collaborate with engineers, regulatory specialists, and manufacturing staff to ensure seamless product development and problem resolution. There may also be tasks related to preparing reports for regulatory submissions or participating in audits. This role offers the opportunity to make a real impact on patient safety while working in a collaborative, fast-paced environment.
What is medical device testing?
A Medical Device Testing job involves evaluating medical devices to ensure they meet regulatory standards, safety guidelines, and performance requirements. Professionals in this role conduct tests, analyze data, and document results to verify compliance with industry regulations such as FDA, ISO, and IEC standards. They work with engineers and regulatory teams to identify design flaws, improve product safety, and ensure reliability before market release. This job is crucial for preventing defects that could impact patient health and safety.
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Full-time
Medical, Retirement, PTO
Re-posted 24 days ago
Job description
CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious diseases such as COVID-19, pregnancy, drug abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Position Summary
The Regulatory Affairs Specialist will support the preparation, review, and submission of regulatory documentation for medical device/IVDs products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position focus on submitted documents preparing, helping to secure timely product approvals and regulatory clearances.
Key Responsibilities
- Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies
- Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards
- Working on analytical performance test with product development teams to draft documentation.
- Perform regulatory assessments for product changes and propose appropriate regulatory pathways
- Maintain documentation and records of all regulatory submissions and correspondence
- Support the preparation for regulatory agency meetings, audits, and inspections
Requirements
Education:
- Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required
Language:
- English
- Mandarin Preferred
Professional Experience:
- 2-3 years of regulatory affairs experience within the medical device or IVD industry
- Working knowledge of 510(k) submissions and regulatory documentation processes
- Experience interacting with FDA and other regulatory agencies preferred
Skills & Competencies:
- Solid understanding of FDA regulations and Guidance. (510k, PMA, De novo)
- Strong organizational and project management skills with the ability to manage multiple projects and priorities
- Excellent communication, problem-solving, and attention to detail
- Ability to work collaboratively in cross-functional teams and manage document workflows
Benefits
- Comprehensive medical insurance.
- 401(k) plan with company contributions.
- Flexible paid time off (PTO) policy.
About CorDx
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
1,001 - 5,000 Employees
Headquarters location
Atlanta, GA, US
Year founded
2006