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Validation Engineer Biomedical Jobs in Raleigh, NC

NIRSense Inc.

Senior Electrical Engineer

Morrisville, NC · On-site

$100K - $131K/yr

... validation. * Deep hands-on expertise with design and integration of electrical components of ... S. in Electrical or Biomedical Engineering or a related field. Preferred Qualifications:

Apply Early

NIRSense Inc

Senior Electrical Engineer

Morrisville, NC · On-site

$100K - $131K/yr

... validation. * Deep hands-on expertise with design and integration of electrical components of ... S. in Electrical or Biomedical Engineering or a related field. Preferred Qualifications:

NIRSense Inc

Senior Electrical Engineer

Morrisville, NC · On-site

$100K - $131K/yr

... validation. * Deep hands-on expertise with design and integration of electrical components of ... S. in Electrical or Biomedical Engineering or a related field. Preferred Qualifications:

Next Step Systems

Senior Firmware Engineer

Durham, NC · On-site

$115K - $152K/yr

Responsibilities: - Implement algorithms for biomedical instrumentation. - Create design ... validate and execute engineering verification test plans. - Document designs, implement tests ...

CoVar

Machine Learning Engineer

Durham, NC

We develop AI/ML tools to help the DoD detect enemies and threats, help biomedical researchers find ... Deep understanding of machine learning fundamentals (gradient descent, cross-validation, ROC curves ...

MLS Technologies

Senior Mechanical Engineer

Apex, NC

$80K - $105K/yr

... and validate prototype systems using in-house 3D printed and molded components Follow best ... S in Mechanical or Biomedical Engineering or a related field Eight or more years industry ...

MLS Technologies

Senior Mechanical Engineer

Apex, NC · On-site

$80K - $105K/yr

... and validate prototype systems using in-house 3D printed and molded components Follow best ... S. in Mechanical or Biomedical Engineering or a related field Eight or more years industry ...

Recruiting Engine (MLS)

Senior Mechanical Engineer

Apex, NC

$80K - $105K/yr

... and validate prototype systems using in-house 3D printed and molded components Follow best ... S. in Mechanical or Biomedical Engineering or a related field Eight or more years industry ...

Apply Early

CoVar

Signal Processing Engineer

Durham, NC

We develop AI/ML tools to help the DoD detect enemies and threats, help biomedical researchers find ... Performance Evaluation: Conduct laboratory and field testing to validate system performance under ...

Apply Early

Tekni-Plex

Operations Quality Engineer

Clayton, NC · On-site

$61K - $79K/yr

Participate in process validations, risk management activities, and quality planning as required ... Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related field) preferred ...

Tekni-Plex

Operations Quality Engineer

Clayton, NC · On-site

$61K - $79K/yr

Participate in process validations, risk management activities, and quality planning as required ... Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related field) preferred ...

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All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Raleigh, NC

Validation Engineer Biomedical information

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How much do validation engineer biomedical jobs pay per hour?

As of Jul 1, 2026, the average hourly pay for validation engineer biomedical in Raleigh, NC is $50.54, according to ZipRecruiter salary data. Most workers in this role earn between $38.32 and $61.44 per hour, depending on experience, location, and employer.

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are some typical challenges faced by Validation Engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What are the key skills and qualifications needed to thrive as a Validation Engineer in Biomedical, and why are they important?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What does a Validation Engineer do in the biomedical field?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.
What are popular job titles related to Validation Engineer Biomedical jobs in Raleigh, NC? For Validation Engineer Biomedical jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Validation Engineer Biomedical jobs in Raleigh, NC look for? The top searched job categories for Validation Engineer Biomedical jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Validation Engineer Biomedical jobs? Cities near Raleigh, NC with the most Validation Engineer Biomedical job openings:
Validation Engineer Biomedical jobs near you
Senior Electrical Engineer

Senior Electrical Engineer

NIRSense Inc.

Morrisville, NC • On-site

$100K - $131K/yr

Full-time

Posted 21 days ago

Be an early applicant

Job description

Salary:

Minimum Qualifications:

  • 5+ years of experience in electrical engineering, with significant focus on medical devices or biomedical sensing systems.
  • Demonstrated ability to independently lead and deliver complex medical device hardware development projects from concept through design verification and validation.
  • Deep hands-on expertise with design and integration of electrical components of miniaturized medical device systems such as PCBs, PCB components, batteries, and light-emitting and detecting systems.
  • Expertise in mixed-signal circuit design for physiological sensing, including signal generators, amplifiers, filters, ADCs, and low-noise data acquisition systems.
  • Experience designing low-power architectures and battery management systems for body-worn medical devices.
  • Experience with EMC/EMI design practices and electrical safety standards (IEC 60601-1, IEC 60601-1-2).
  • Experience leading formal design reviews and presenting technical analyses to cross-functional stakeholders in a design-controlled environment.
  • Proficiency in PCB design tools (Altium Designer preferred), including rigid, flex, and rigid-flex designs for space-constrained wearable form factors.
  • Strong technical writing skills, with experience authoring design documentation for regulated environments.
  • Experience managing PCB fabricator and contract manufacturer relationships, including vendor qualification and supply chain risk mitigation.
  • B.S. in Electrical or Biomedical Engineering or a related field.

Preferred Qualifications:

  • Knowledge of biosensing and electrical stimulation technologies and proficiency in hardware implementations of these technologies.
  • Experience with optoelectronic circuit design, including LED drivers, photodiode front-ends, and transimpedance amplifiers (TIAs).
  • Experience with mechanical-electrical integration for miniaturized wearable enclosures and collaboration with mechanical engineering teams.
  • Familiarity with C/C++ and embedded systems integration with BLE-enabled microcontrollers (e.g., Nordic nRF series) for wireless physiological data streaming.
  • Experience directing and reviewing work from external PCB layout and design contractors.
  • Experience designing medical wearable hardware for manufacturability (DFM) and testability (DFT), including development of test fixtures and validation systems.
  • Experience with design verification and validation (V&V) testing in a regulated medical device environment.
  • Experience supporting FDA regulatory submissions (e.g., 510(k), de novo) and familiarity with design controls under 21 CFR Part 820 or ISO 13485.
  • Experience with hardware FMEA and risk management per ISO 14971.

Job Responsibilities:

  • Design low-power architectures, battery charging circuits, and power budgets for portable and wearable device platforms.
  • Design for safety and electromagnetic compatibility (EMC/EMI), conduct pre-compliance testing, and support formal EMC and electrical safety testing per IEC 60601-1 and IEC 60601-1-2.
  • Drive and lead design reviews with multi-disciplinary stakeholders, establishing rigorous engineering practices and collaborating closely with firmware, mechanical, and software engineers to ensure seamless system integration.
  • Independently manage relationships with PCB fabricators and assemblers; oversee BOM cost, sourcing risk, and component lifecycle to supply finished, high-quality electronics.
  • Lead test fixture design and manufacturing test strategy, from prototype PCB evaluation through design transfer and production yield optimization.
  • Author and review technical reports, maintain schematic libraries and design history files (DHF), and contribute hardware FMEA and risk management files (ISO 14971) to support regulatory submissions (510(k), de novo).
  • Report to the Electrical Engineering R&D Manager.
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About NIRSense

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

11 - 50 Employees

Headquarters location

Richmond, VA, US

Year founded

2018

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