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Validation Engineer Medical Devices Jobs (NOW HIRING)

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II supports a broad range of software-enabled medical devices within a product suite that includes intraoperative neuromonitoring, surgical alignment, robotic navigation, and ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II supports a broad range of software-enabled medical devices within a product suite that includes intraoperative neuromonitoring, surgical alignment, robotic navigation, and ...

Pinnaql

Validation Engineer - Upstream

Juana Diaz, PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA

The Validation Engineer II supports a broad range of software-enabled medical devices within a product suite that includes intraoperative neuromonitoring, surgical alignment, robotic navigation, and ...

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How much do validation engineer medical devices jobs pay per hour?

As of Aug 15, 2026, the average hourly pay for validation engineer medical devices in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What is a validation engineer medical devices?

A Validation Engineer in medical devices ensures that products, processes, and equipment meet regulatory and quality standards. They develop and execute validation protocols, conduct tests, analyze data, and document results to ensure compliance with FDA, ISO 13485, and other regulations. Their role is crucial in verifying that medical devices are safe, effective, and consistent in performance before they reach the market.

What are some typical challenges faced by validation engineers in the medical device industry?

Validation Engineers in the medical device industry often encounter challenges such as navigating ever-evolving regulatory standards, managing tight project timelines, and ensuring thorough documentation for audits. They are frequently tasked with balancing the need for comprehensive testing and validation with efficiency to support product development cycles. Working closely with cross-functional teams—including design, quality assurance, and manufacturing—requires strong collaboration and adaptability. Overcoming these challenges helps ensure that medical devices are safe, effective, and compliant with industry regulations, making the role both demanding and highly impactful.

What are the key skills and qualifications needed to thrive as a validation engineer medical devices?

A Validation Engineer in Medical Devices needs a strong background in biomedical engineering or a related field, knowledge of regulatory requirements (such as FDA or ISO 13485), and expertise in validation methodologies. Familiarity with tools like statistical analysis software, quality management systems (QMS), and documentation platforms is often required, as well as certifications such as CQE (Certified Quality Engineer). Strong attention to detail, problem-solving abilities, and effective communication skills are essential to excel in this role. These competencies are critical to ensure medical devices meet rigorous safety and compliance standards, protecting patient health and supporting successful product launches.

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Validation Engineer Medical Devices jobs near you
Infographic showing various Validation Engineer Medical Devices job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

System Engineer - Medical Devices

Global Connect Technologies

Bloomington, MN • On-site

Other

Posted 26 days ago

Job description

Job Title: Sr. Systems Engineer

Location: West Bloomington, MN

Job Type: Full-Time


Summary

The Sr. Systems Engineer leads architecture design, requirements development, and lifecycle management of complex electromechanical and embedded systems. This role serves as the technical lead across multiple programs, ensuring systems are verified, validated, and aligned with performance, safety, manufacturability, and business objectives. The position collaborates cross-functionally and with customers to translate market needs into scalable, reliable system solutions.

Key Responsibilities

  • Own system and subsystem architecture and requirements across the full product lifecycle
  • Develop clear, testable requirements and maintain traceability through verification and validation
  • Perform system-level analysis, simulation, and risk assessments to ensure performance, safety, and reliability
  • Lead technical execution of projects, including requirements definition and design reviews
  • Translate market and customer needs into system architectures and engineering requirements
  • Partner cross-functionally with electrical, mechanical, firmware, and software teams
  • Define and maintain verification and validation plans, test cases, and requirements traceability
  • Implement tools and processes to track requirements, quality, and project progress
  • Serve as primary technical point of contact, ensuring adherence to standards and development processes
  • Support multiple concurrent programs, managing priorities and communicating status, risks, and outcomes
  • Contribute to risk identification, mitigation strategies, and compliance with relevant standards
  • Drive continuous improvement in systems engineering, requirements management, and testing processes
  • Participate in technical talent evaluation and development

Required Qualifications

  • Bachelor’s degree in engineering
  • 5+ years of engineering experience, including:
  • 2+ years in requirements management
  • 2+ years with electromechanical systems
  • Experience with embedded systems, including hardware/firmware integration
  • Proven ability to develop and manage system architectures and multi-domain requirements
  • Experience with requirements and test management tools (e.g., DOORS, Jira)
  • Strong understanding of embedded systems, connected solutions, and cybersecurity considerations
  • Experience in regulated or high-reliability environments (e.g., industrial safety, aerospace, medical)
  • Strong communication, analytical, and problem-solving skills
  • Ability to lead technical discussions, manage multiple priorities, and work cross-functionally
  • Familiarity with structured development processes (e.g., ASPICE, Agile/Scrum)

Preferred Qualifications

  • Degree in Systems, Electrical, Computer, or Software Engineering
  • Experience with high hazard or safety-critical systems (e.g., SIL2)
  • Experience in regulated industries (e.g., aerospace, medical devices)
  • Experience with ASPICE and Agile development environments
  • Skilled in risk analysis, verification planning, and process improvement
  • Ability to mentor or assess engineering talent

Apply