Search Jobs | Dice.com

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: a54ca3d6200aef9f009c60b2e274b876
Posted 2 days ago

Fitment

Dice Job Match Score™

👾 Reticulating splines...

Create job alert

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

Similar Jobs

Principal Systems Verification Engineer

Round Lake, Illinois

•

Today

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboratio

Full-time

USD 112,000.00 - 154,000.00 per year

Validation Engineer

Kenosha, Wisconsin

•

Today

Requirements: Experienced Validation Engineer with either minimum 3 years experience or Sr. Validation Engineer with minimum 5 years experience performing Validation on aseptic liquid fill manufacturing equipment. utoclaves and Parts Washer experience important. The work is specifically performing Cycle Development and PQ/PV on equipment. Heavy experience with IQ, OQ and PQ of autoclaves and parts washers would work as well. Project is very schedule driven with mostly overnight shifts. Project i

Full-time

Senior CSV Engineer

Chicago, Illinois

•

Today

Job Description: The Senior Computer System Validation (CSV) Engineer is responsible for leading validation activities for computerized systems used in regulated environments such as pharmaceutical, biotechnology, or medical device manufacturing. This role ensures that systems including LIMS, ERP, MES, and laboratory applications are validated in compliance with FDA, EU, and global regulatory requirements. The Senior CSV Engineer will act as a subject matter expert (SME), providing guidance on

Full-time

Validation Lead(Computer System Validation GenAI, Agentic QMS)

Remote or New Jersey

•

Today

Validation Lead(Computer System Validation GenAI, Agentic QMS) Raritan, NJ (Onsite - Hybrid) Long Term Contract Job Details: Experience in the Pharmaceutical, biotechnology, or medical device industry Experience with Validation of GEN AI solutions in GxP environment is key 2+ years' experience with System Development Lifecyle 3+ years' experience in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validatio

Easy Apply

Contract

Filter Results

Job post features

Posted date

Work settings

Employment type

Distance

Employer type

Work authorization

Validation Engineer

Skills

Summary

Dice Job Match Score™

Similar Jobs

Validation Engineer

Job Details

Skills

Summary

Dice Job Match Score™

Similar Jobs