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Validation Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts • Today

Full-time

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Alkermes, Inc

Waltham, Massachusetts • Today

Full-time

USD 110,000.00 - 126,000.00 per year

Silicon Validation Engineer

Apple, Inc.

Waltham, Massachusetts • Today

Full-time

Validation Engineer 2 - Product R&D

Merck KgaA

Bedford, Massachusetts • Today

Full-time

USD 84,900.00 - 127,300.00 per year

Junior Validation Engineer with CSV / CQV

Arthur Lawrence

Cambridge, Massachusetts • 13d ago

Easy Apply

Contract, Third Party

$30 - $39

Validation Engineer

Katalyst Healthcares and Lifesciences

Boxborough, Massachusetts • Today

Full-time

Verification & Validation Test Engineer

IPG Photonics Corp

Marlborough, Massachusetts • Today

Full-time

Sr AI Validation Engineer

Cloud Destinations LLC

Remote • 5d ago

Easy Apply

Contract

$80 - $90

Integration Validation Engineer- VHA Finance

HigherEchelon

Remote • Today

Full-time

Post-Silicon Systems Software Validation Engineer

Arrow Electronics, Inc.

Remote or California • Today

Full-time

USD 87,400.00 - 165,000.00 per year

Sr AI Validation Engineer

Cloud Destinations LLC

Remote • Yesterday

Easy Apply

Contract

$80+

Data Validation Engineer

GlobalLogic Inc.

Remote • 28d ago

Easy Apply

Full-time

100000 - 110000

Validation Engineer - GPU Systems

Cloud Destinations LLC

Remote • Today

Easy Apply

Contract

Depends on Experience

Senior Engineer Test Method Validation

Innova Solutions, Inc

North Andover, Massachusetts • 16d ago

Easy Apply

Contract

$95 - $107

Principal Electrical Engineer - Server Hardware Validation

Oracle Corporation

Burlington, Massachusetts • Today

Full-time

USD 114,600.00 - 234,600.00 per year

Principal Engineer, Hardware & Silicon Validation

Marvell Semiconductor Inc.

Westborough, Massachusetts • Today

Full-time

USD 169,300.00 - 250,530.00 per year

Staff Systems Engineer - Release Strategy & Validation

Torc Robotics

Remote or Ann Arbor, Michigan • Today

Full-time

USD 168,800.00 - 202,600.00 per year

Engineer Pharma Validation

Medline Industries, LP

Remote • Today

Full-time

USD 73,000.00 - 110,000.00 per year

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

CSV Engineer

Katalyst Healthcares and Lifesciences

Woburn, Massachusetts • Today

Full-time

Validations/ Verifications Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts • Today

Full-time

QA Analyst - UI & Data Validation (Remote)

Kforce Technology Staffing

Remote or Commerce, California • Today

Contract

$35 - $50 hourly

Staff RF Test Development Engineer

Qorvo, Inc.

Chelmsford, Massachusetts • Today

Full-time

USD 125,400.00 - 163,000.00 per year

Senior Machine Learning Engineer, Core Algorithms

Whoop

Boston, Massachusetts • Today

Full-time

USD 150,000.00 - 210,000.00 per year

Lead Data Engineer

General Dynamics

Remote • Today

Full-time

USD 128,039.00 - 173,229.00 per year

Automation QA Engineer

Acunor Infotech

Remote • Today

Easy Apply

Contract, Third Party

Validation Engineer

Katalyst Healthcares and Lifesciences

Waltham, Massachusetts • Today

Full-time

IRS CAS (Sr Software Developer/Infrastructure Currency Engineer)

Constellation West

Remote • Today

Full-time

Pharma IT Testing & Validation Delivery Lead

TATA Consultancy Services Limited

Boston, Massachusetts • 25d ago

Easy Apply

Full-time

110,000 - 130,000

Senior Systems Data Scientist, Behavior Validation

General Motors

Remote or Sunnyvale, California • Today

Full-time

USD 148,000.00 - 226,200.00 per year

Job Details

Skills

Regulatory Compliance
Test Plans
Testing
Issue Resolution
Collaboration
Research and Development
Manufacturing
Systems Engineering
Risk Management
System Requirements
Design Review
Electromechanics
Verification And Validation
Design Controls
Quality Management
Communication
Documentation
ISO 13485
Medical Devices

Summary

Job Summary:

We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products.
The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
Experience with infusion pump systems or similar electromechanical medical devices is preferred.

Roles & Responsibilities:

Plan and execute system-level Verification & Validation (V&V) activities for medical device products.
Develop, review, and execute validation protocols, test plans, and test reports.
Perform validation testing, document results, investigate failures, and support issue resolution.
Ensure validation activities comply with applicable quality standards, regulatory requirements, and internal procedures.
Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Systems Engineering.
Support design verification, risk management, and product validation efforts.
Maintain accurate documentation in accordance with FDA, ISO 13485, and company quality system requirements.
Participate in design reviews and provide technical input related to system validation.

Education & Experience:

Bachelor's degree in Engineering or a related technical discipline.
Minimum 10 years of Validation Engineering experience.
Strong experience in the Medical Device industry, preferably with infusion pumps or similar electromechanical medical devices.
Hands-on experience with System-Level Verification & Validation (V&V).
Proven experience executing validation protocols, documenting results, and resolving validation issues.
Strong understanding of design controls, validation processes, and quality systems.
Excellent communication and documentation skills.
Preferred: Experience working with FDA-regulated medical devices.
Preferred: Knowledge of ISO 13485, 21 CFR Part 820, IEC 60601, and related medical device standards.
Preferred: Previous experience with client or other leading medical device manufacturers.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: d90d7c18c7b642faa030f37888529dee
Posted 9 hours ago

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Similar Jobs

Validations/ Verifications Engineer

Boston, Massachusetts

•

Today

Role Descriptions: Must Have Technical/Functional Skills Desirable Skills: Skills: EIS: Medical Device & Regulations ~EIS: New Product Development (NPD) Methodology and Management Experience Required: 4-6 5+ years of work experience in medical device industry Required: A bachelor's degree in Technical or Scientific discipline 5+ years of work experience in medical device industry Experience conducting Process Verifications / Validations Experience conducting Design and/or Process Failure M

Full-time

Verification & Validation Test Engineer

Marlborough, Massachusetts

•

Today

IPG Photonics is revolutionizing the laser industry as the pioneering developer and leading producer of fiber lasers and amplifiers. Headquartered in Marlborough, MA, IPG has over 4,800 employees in more than 30 locations around the world. We aspire to work together with our employees and customers to apply light in ways that improve life. Our mission is to develop innovative laser solutions to make the world a better place. To accomplish this mission, we are committed to attracting and retainin

Full-time

Senior Systems Test Engineer - Electrophysiology

Waltham, Massachusetts

•

Today

Additional Location(s): US-MN-Arden Hills Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing -

Full-time

USD 89,200.00 - 169,500.00 per year

Design Assurance Engineer / Medical Devices

Marlborough, Massachusetts

•

Today

A leading global technology company is looking for a Design Assurance Engineer to join its team in Marlborough, MA. This is a great opportunity for an engineer with 3-5 years of medical device experience who wants to take on meaningful work across the full product development lifecycle. You'll help develop and improve Class II electro-mechanical medical devices while working closely with Design Engineering, Quality, Regulatory, and external testing teams. You'll have the opportunity to work on p

Easy Apply

Full-time

$74000 - $105000

Job Details

Skills

Regulatory Compliance
Test Plans
Testing
Issue Resolution
Collaboration
Research and Development
Manufacturing
Systems Engineering
Risk Management
System Requirements
Design Review
Electromechanics
Verification And Validation
Design Controls
Quality Management
Communication
Documentation
ISO 13485
Medical Devices

Summary

Job Summary:

We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products.
The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
Experience with infusion pump systems or similar electromechanical medical devices is preferred.

Roles & Responsibilities:

Plan and execute system-level Verification & Validation (V&V) activities for medical device products.
Develop, review, and execute validation protocols, test plans, and test reports.
Perform validation testing, document results, investigate failures, and support issue resolution.
Ensure validation activities comply with applicable quality standards, regulatory requirements, and internal procedures.
Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Systems Engineering.
Support design verification, risk management, and product validation efforts.
Maintain accurate documentation in accordance with FDA, ISO 13485, and company quality system requirements.
Participate in design reviews and provide technical input related to system validation.

Education & Experience:

Bachelor's degree in Engineering or a related technical discipline.
Minimum 10 years of Validation Engineering experience.
Strong experience in the Medical Device industry, preferably with infusion pumps or similar electromechanical medical devices.
Hands-on experience with System-Level Verification & Validation (V&V).
Proven experience executing validation protocols, documenting results, and resolving validation issues.
Strong understanding of design controls, validation processes, and quality systems.
Excellent communication and documentation skills.
Preferred: Experience working with FDA-regulated medical devices.
Preferred: Knowledge of ISO 13485, 21 CFR Part 820, IEC 60601, and related medical device standards.
Preferred: Previous experience with client or other leading medical device manufacturers.

Dice Id: 91116760
Position Id: d90d7c18c7b642faa030f37888529dee
Posted 9 hours ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Validations/ Verifications Engineer

Boston, Massachusetts

•

Today

Full-time

Verification & Validation Test Engineer

Marlborough, Massachusetts

•

Today

Full-time

Senior Systems Test Engineer - Electrophysiology

Waltham, Massachusetts

•

Today

Full-time

USD 89,200.00 - 169,500.00 per year

Design Assurance Engineer / Medical Devices

Marlborough, Massachusetts

•

Today

Easy Apply

Full-time

$74000 - $105000