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Quality Engineer Medical Devices Jobs (NOW HIRING)

Agiliad

Medical Test Engineer

Boston, MA · On-site

Collaborate closely with cross-functional teams including R&D, firmware, hardware, systems engineering, and quality assurance teams. Required Skills: * Strong experience in Medical Devices domain ...

Della Infotech Inc.

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Supplier Process Engineer (Medical Devices)

Norcross, GA · On-site

$54 - $64/hr

The Supplier Engineer partners closely with Manufacturing, Quality, Planning, Operations, Design ... Experience supporting high-volume manufacturing environments, preferably in medical devices or ...

Intellectt INC

Quality Engineer

Chicago, IL · On-site

$74K - $95K/yr

... in Medical Devices, Pharmaceuticals, or regulated Healthcare Manufacturing • Strong knowledge of 21 CFR Part 820 and/or ISO 13485 • Experience with DMRs, DHFs, Design Controls, Risk Management ...

Exalta Group

Quality Engineer

Bethlehem, PA · On-site

$65K - $75K/yr

The Quality Engineer plays a key role in supporting the organization's Quality Management System ... Experience supporting orthopedic, implantable, or Class II/III medical devices. * Familiarity with ...

Theragenics Corp

Quality Engineer

Attleboro Falls, MA · On-site

$97K - $115K/yr

... a Quality Engineer (V&V) and help drive the production of life-saving medical devices used in ... Theragenics is a leader in developing medical devices that focus on minimally invasive treatments ...

Theragenics Corp

Quality Engineer

Attleboro Falls, MA · On-site

$97K - $115K/yr

... a Quality Engineer (V&V) and help drive the production of life-saving medical devices used in ... Theragenics is a leader in developing medical devices that focus on minimally invasive treatments ...

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Quality Engineer Medical Devices information

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$45K

$84K

$119K

How much do quality engineer medical devices jobs pay per year?

As of Jun 13, 2026, the average yearly pay for quality engineer medical devices in the United States is $84,039.00, according to ZipRecruiter salary data. Most workers in this role earn between $72,000.00 and $93,000.00 per year, depending on experience, location, and employer.

What does a Quality Engineer do in the medical device industry?

A Quality Engineer in the medical device industry is responsible for ensuring that products meet regulatory standards and quality requirements throughout their lifecycle. They develop and implement quality control processes, conduct risk assessments, lead investigations into product defects, and work closely with cross-functional teams to ensure compliance with regulations such as FDA and ISO 13485. Their work helps to guarantee the safety, reliability, and effectiveness of medical devices before they reach patients.

How does a Quality Engineer collaborate with cross-functional teams in the medical device industry?

Quality Engineers in the medical device field work closely with design, manufacturing, and regulatory teams to ensure products meet stringent quality and compliance standards. They participate in design reviews, help develop verification and validation protocols, and support the implementation of corrective actions. Regular communication with production and R&D teams is essential to identify potential risks early and to ensure that quality is built into every stage of product development. This collaborative approach not only improves product safety and efficacy but also streamlines regulatory submissions and audits.

What is the difference between Quality Engineer Medical Devices vs Quality Technician Medical Devices?

AspectQuality Engineer Medical DevicesQuality Technician Medical Devices
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 13485, basic quality certifications
ResponsibilitiesDesigning quality systems, process improvements, root cause analysisInspecting products, conducting tests, recording quality data
Work EnvironmentDesign and development labs, manufacturing plantsManufacturing floors, quality control labs
Employer & Industry UsageMedical device companies, OEMs, suppliersManufacturers, contract labs, quality departments

In summary, Quality Engineer Medical Devices focus on developing quality systems, process improvements, and ensuring compliance, while Quality Technicians primarily perform product inspections and testing. Both roles are essential in maintaining high standards in the medical device industry but differ in scope and responsibilities.

What are the key skills and qualifications needed to thrive as a Quality Engineer in Medical Devices, and why are they important?

To thrive as a Quality Engineer in Medical Devices, you typically need a degree in engineering or a related field, combined with knowledge of quality assurance principles and regulatory requirements (such as ISO 13485 and FDA regulations). Familiarity with risk management tools, validation protocols, and quality management systems (QMS), as well as certifications like CQE (Certified Quality Engineer), are highly valuable. Strong analytical thinking, attention to detail, and effective communication skills enable you to identify issues, collaborate with cross-functional teams, and ensure compliance. These competencies are crucial for maintaining product safety, meeting regulatory standards, and supporting a culture of continuous improvement in the medical device industry.
More about Quality Engineer Medical Devices jobs
What cities are hiring for Quality Engineer Medical Devices jobs? Cities with the most Quality Engineer Medical Devices job openings:
What states have the most Quality Engineer Medical Devices jobs? States with the most job openings for Quality Engineer Medical Devices jobs include:
What job categories do people searching Quality Engineer Medical Devices jobs look for? The top searched job categories for Quality Engineer Medical Devices jobs are:
Quality Engineer Medical Devices jobs near you
Infographic showing various Quality Engineer Medical Devices job openings in the United States as of June 2026, with employment types broken down into 80% Full Time, 12% Part Time, and 8% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $84,039 per year, or $40.4 per hour.

Medical Test Engineer

Agiliad

Boston, MA • On-site

Full-time

Posted 2 days ago

Job description

Test Engineer - Medical Devices (Cardiovascular Domain)
Job Title:
Test Engineer / Senior Test Engineer - Medical Devices (Cardiovascular)
Experience: 5-10 Years
Location:
Boston, MA, USA
Job Summary:
We are looking for a highly skilled Test Engineer with strong experience in the Medical Devices domain, specifically in Cardiovascular/Cardiac devices. The candidate will be responsible for Verification & Validation (V&V), Design Verification Testing (DVT), reliability testing, and system-level validation of complex electro-mechanical medical devices.
The ideal candidate should have hands-on experience with test instrumentation, data acquisition systems, embedded interfaces, and regulatory-driven medical device testing in an FDA-regulated environment.
Key Responsibilities:
  • Understand device design, system architecture, and core technologies to support effective test method development for cardiovascular medical devices.
  • Generate and execute test plans, protocols, and procedures derived from product functional requirements, feasibility studies, and risk analysis activities.
  • Lead and conduct Design Verification Testing (DVT), including extended reliability and stress testing activities.
  • Develop detailed test protocols, procedures, traceability documentation, and final test reports.
  • Select, configure, and validate test instrumentation, fixtures, and data acquisition systems as required by testing standards and product requirements.
  • Configure and operate test fixtures, sensors, and instrumentation for electrical, mechanical, pressure, temperature, and flow-based testing.
  • Perform troubleshooting and analysis using oscilloscopes, multi-meters, function generators, power supplies, and pressure/flow measurement transducers.
  • Work with communication interfaces such as UART, USB, and CAN for device-level validation and debugging.
  • Perform system, integration, functional, regression, and reliability testing for cardiovascular and medical device applications.
  • Train engineers and technicians on testing methodologies, protocols, and lab equipment usage.
  • Maintain accurate documentation, test records, and traceability matrices in compliance with FDA, ISO 13485, and IEC 60601 standards.
  • Collaborate closely with cross-functional teams including R&D, firmware, hardware, systems engineering, and quality assurance teams.

Required Skills:
  • Strong experience in Medical Devices domain with exposure to Cardiovascular/Cardiac devices.
  • Hands-on experience in Verification & Validation (V&V) and Design Verification Testing (DVT).
  • Knowledge of FDA-regulated medical device development lifecycle and design controls.
  • Experience with reliability testing and system-level testing.
  • Experience with test instrumentation and lab equipment.
  • Knowledge of communication interfaces such as UART, USB, and CAN.
  • Basic scripting/programming experience in Python.
  • Strong debugging, analytical, and problem-solving skills.
  • Understanding of IEC 60601, ISO 13485, and medical device compliance standards.

Qualifications:
  • BS/MS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, or related field.
  • Minimum 5+ years of experience in Verification & Validation within Medical Devices domain.
  • Experience working on Cardiovascular, Cardiac Monitoring, Heart Pump, ECG/EKG, or similar medical systems is highly preferred.

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