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Katalyst Healthcares and Lifesciences

Rochester, New York • Today

Full-time

Senior Software Verification and Validation Engineer (Medical Devices or Lab or Diagnostics) W2 Candidates only (Open to relocation)

JSB Staffing Solutions, Pvt. Ltd.

Rochester, New York • 6d ago

Easy Apply

Full-time

$140,000 - $160,000

Sr. Computer Systems Validation Engineer

CooperCompanies

Remote or Trumbull, Connecticut • Today

Full-time

USD 96,441.00 - 126,000.00 per year

Senior DevOps Validation Engineer

Keeper Security, Inc.

Remote • Today

Full-time

Senior Software Systems Engineer, Autonomous Systems Validation Confidence

General Motors

Remote or Sunnyvale, California • Today

Full-time

USD 153,200.00 - 234,100.00 per year

Sr. Business Systems Analyst - Validation (CSA) Governance & Process Support

Arthrex

Remote • Today

Full-time

To define

Integration Validation Engineer- VHA DSO

HigherEchelon

Remote • Today

Full-time

Data Validation Engineer

ICF Consulting Group, Inc.

Remote or Reston, Virginia • Today

Full-time

USD 98,614.00 - 167,644.00 per year

Cybersecurity Validation and Test Engineer

Amyx Inc

Remote • Today

Full-time

USD 100,000.00 - 140,000.00 per year

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

SAP Validation

Devfi

Remote • 10d ago

Easy Apply

Contract

Depends on Experience

ETL Developer ( Data migration, Data Validation, SQL, Workday, Peoplesoft ) 15+ years of experience

ACS Consultancy Services, Inc.

Remote or New York, New York • Yesterday

Easy Apply

Full-time

Engineering Manager, Verification and Validation (STATCOM)

GE Vernova

Remote • Today

Full-time

USD 113,200.00 - 188,800.00 per year

Integration Engineer-Plano, TX

Motion Recruitment Partners, LLC

Remote or Plano, Texas • Today

Easy Apply

Contract

Validation Engineer (Medical Device)

Caresoft

Rochester, New York • Today

Easy Apply

Contract

Validation Engineer

Katalyst Healthcares and Lifesciences

Rochester, New York • Today

Full-time

Job Details

Skills

Research and Development
Project Implementation
Regulatory Compliance
Production Engineering
Workflow
Manufacturing
Medical Devices
ISO 13485
Quality Management
ISO 9000
Risk Management
IQ
OQ
PQ
Documentation
Technical Writing
Collaboration
Management
Offshoring
Project Management
Performance Management
Preventive Maintenance
Profit And Loss

Summary

Summary:
We are seeking a highly skilled R&D/Validation Engineer with mandatory experience in the Medical Devices domain. The ideal candidate will be responsible for planning, leading, and coordinating project execution and validation activities in strict alignment
with ISO 13485 and ISO 14971 standards. This role requires a hands-on leader who can manage equipment, process, and product transfers while liaising with global teams and customers to ensure on-time delivery.
Roles & Responsibilities:

Project Leadership: Plan, lead, and coordinate project execution and validation activities, ensuring compliance with regulatory standards (ISO 13485, ISO 14971).
Validation Execution: Support and execute validation planning and protocols for equipment, process, and product transfers, specifically managing IQ (Installation Qualification), OQ (Operational Qualification),and PQ (Performance Qualification).
Documentation & Compliance: Author, review, and approve validation documentation, ensuring traceability and adherence to quality system regulations.
Cross-Functional Collaboration: Collaborate effectively with cross-functional teams (Quality, Production, Engineering) to resolve technical issues and streamline project workflows.
Stakeholder Coordination: Act as the primary point of contact, coordinating with customers, manufacturing plants, and off-shore teams to ensure project continuity and timely delivery.Strategic Contribution: Contribute as a Project Manager (PM) or Project Lead (PL) to drive project milestones is an added advantage.

Skills & Qualifications:

Domain Expertise: Mandatory prior experience in the Medical Devices industry.
Regulatory Knowledge: Deep understanding of ISO 13485 (Quality Management) and ISO 14971 (Risk Management).
Validation Expertise: Proven hands-on experience with IQ, OQ, and PQ protocols for equipment and process transfers.
Documentation: Strong technical writing skills for authoring and reviewing validation protocols/reports.
Coordination: Proven ability to manage cross-functional teams and global stakeholders (offshore and onshore).
Experience as a PM/PL handling full project lifecycles.

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: 4c3e0e2489a133242ecf2ab0cce95daf
Posted 30+ days ago

Fitment

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Rochester, New York

•

6d ago

Position Description : This Senior Software Verification and Validation Engineer position is a direct hire opportunity which is expected to be on-site at clients facility in Rochester, New York. Laboratory / Testing Commitment: Approximately 70% hands-on testing and validation activities. Summary We are seeking an experienced Senior Software Verification and Validation (V&V) Engineer to support the development, integration, verification, and validation of medical devices, diagnostic systems, lab

Easy Apply

Full-time

$140,000 - $160,000

Senior Engineer, Validation

Maryland

•

Today

About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., hous

Full-time

USD 120,000.00 - 140,000.00 per year

Engineer II, Product Processing & Digital Engineering

No location provided

•

Today

Job Description Support product data process development of products for medical devices through the creation and maintenance of digital product processes, testing enterprise systems and business processes, maintaining software validation documents and specifications, testing enterprise systems and business processes. Work closely with Operations, R&D, Quality, Regulatory and IT to optimize engineering processes, integrate digital tools, and enhance data continuity from concept through end-of-l

Full-time

Process Engineer

Scottsville, New York

•

Today

Job Description Provides manufacturing process and project engineering support including process development and continuous improvement activities. Supports the wider business in the introduction of new products and automated processes into manufacturing. Responsibilities Supports the installation, development, and validation of manufacturing processes from concept to implementation.Provides on-going support and monitoring to the manufacturing organization in achieving objectives in respect o

Full-time

USD 75,000.00 - 120,000.00 per year

Job Details

Skills

Research and Development
Project Implementation
Regulatory Compliance
Production Engineering
Workflow
Manufacturing
Medical Devices
ISO 13485
Quality Management
ISO 9000
Risk Management
IQ
OQ
PQ
Documentation
Technical Writing
Collaboration
Management
Offshoring
Project Management
Performance Management
Preventive Maintenance
Profit And Loss

Summary

Project Leadership: Plan, lead, and coordinate project execution and validation activities, ensuring compliance with regulatory standards (ISO 13485, ISO 14971).
Validation Execution: Support and execute validation planning and protocols for equipment, process, and product transfers, specifically managing IQ (Installation Qualification), OQ (Operational Qualification),and PQ (Performance Qualification).
Documentation & Compliance: Author, review, and approve validation documentation, ensuring traceability and adherence to quality system regulations.
Cross-Functional Collaboration: Collaborate effectively with cross-functional teams (Quality, Production, Engineering) to resolve technical issues and streamline project workflows.
Stakeholder Coordination: Act as the primary point of contact, coordinating with customers, manufacturing plants, and off-shore teams to ensure project continuity and timely delivery.Strategic Contribution: Contribute as a Project Manager (PM) or Project Lead (PL) to drive project milestones is an added advantage.

Skills & Qualifications:

Domain Expertise: Mandatory prior experience in the Medical Devices industry.
Regulatory Knowledge: Deep understanding of ISO 13485 (Quality Management) and ISO 14971 (Risk Management).
Validation Expertise: Proven hands-on experience with IQ, OQ, and PQ protocols for equipment and process transfers.
Documentation: Strong technical writing skills for authoring and reviewing validation protocols/reports.
Coordination: Proven ability to manage cross-functional teams and global stakeholders (offshore and onshore).
Experience as a PM/PL handling full project lifecycles.

Dice Id: 91116760
Position Id: 4c3e0e2489a133242ecf2ab0cce95daf
Posted 30+ days ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

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

Rochester, New York

•

6d ago

Easy Apply

Full-time

$140,000 - $160,000

Senior Engineer, Validation

Maryland

•

Today

Full-time

USD 120,000.00 - 140,000.00 per year

Engineer II, Product Processing & Digital Engineering

No location provided

•

Today

Full-time

Process Engineer

Scottsville, New York

•

Today

Full-time

USD 75,000.00 - 120,000.00 per year

Senior Validation Engineer

Skills

Summary

Dice Job Match Score™

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Senior Validation Engineer

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Summary

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