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Verification Strategy Lead

Saicon Consultants Inc.

Andover, Minnesota • 7d ago

Easy Apply

Contract, Third Party

Depends on Experience

Lead Cybersecurity Analyst - Payment Fraud Strategy

Target Corporation

Brooklyn Park, Minnesota • Today

Full-time

USD 115,000.00 - 206,000.00 per year

IT Project Manager & Learning Strategy Lead (PMP)

Convene Inc.

Remote • 29d ago

Easy Apply

Contract, Third Party

$65 - $70

Senior GTM Strategy Lead - AI & Strategic initiatives

Alteryx

Remote or California • Today

Full-time

USD 160,000.00 - 184,000.00 per year

Staff Software Development Engineer (myPBM Strategy & Operations Lead)

CVS Health

Remote or Texas • Today

Full-time

USD 118,450.00 - 236,900.00 per year

UX Strategy Lead

Beacon Systems, Inc

Remote or Washington, District of Columbia • 6d ago

Easy Apply

Full-time

Depends on Experience

Web Strategy, SEO & AI Lead

Harness

Remote • Today

Full-time

USD 130,000.00 - 150,000.00 per year

Lead Account Strategy Partner (Forward-Deployed, Healthcare Data)

Pear

Remote or New York, New York • Today

Full-time

USD 150,000.00 - 180,000.00 per year

Senior Manager, Experience Strategy & Web Performance

Covista

Minneapolis, Minnesota • Today

Full-time

Compensation information provided in the description

AI Workforce Strategy & Organization Design Consultant

Medtronic

Minneapolis, Minnesota • Today

Full-time

USD 145,600.00 - 218,400.00 per year

ERP test lead

York Solutions, LLC

Remote or Hybrid • Today

Easy Apply

Contract

$80-$90 an hour

Commercial Pricing and Business Strategy Senior Principal

SAIC

Remote • Today

Full-time

USD 120,001.00 - 160,000.00 per year

Commercial Pricing and Business Strategy Senior Principal

SAIC

Remote • Today

Full-time

USD 120,001.00 - 160,000.00 per year

Senior Director, Analyst - Technology-Drive Strategy and Strategic Planning, Remote - US

Gartner

Remote or Texas • Today

Full-time

USD 172,000.00 per year

Sr Director, AI Strategy & Architecture

BeyondTrust Software

Remote • Today

Full-time

AI and Data Science Strategy Leader - Crimson AI - Remote

UnitedHealth Group

Remote or Eden Prairie, Minnesota • Today

Full-time

USD 134,600.00 - 230,800.00 per year

GTM Strategy and Execution Manager -- Ex-McKinsey or BCG Required

Key Infotek LLC

Remote • Today

Easy Apply

Full-time

Depends on Experience

AI Strategy Consultant

Hightouch

Remote • Today

Full-time

USD 170,000.00 - 200,000.00 per year

Mainframe Transformation & Vendor Strategy Consultant

Arcadia Talent Advisory LLC

Remote or Hybrid in Toronto, Ontario • Today

Easy Apply

Contract

Up to $80

AI Strategy Director

Novanta Inc

Remote • Today

Full-time

USD 160,400.00 - 256,600.00 per year

Engagement Manager, IT Strategy, Oracle ERP

Gartner

Remote or Utah • Today

Full-time

USD 138,000.00 per year

AI Strategy & Transformation Architect

NeuraFlash, Part of Accenture

Remote • Today

Full-time

System Test and Validation Lead

Deloitte

Remote or Arlington Heights, Illinois • 12d ago

Full-time

USD 95,000.00 - 145,000.00 per year

Test Lead

Infourge.net

Remote • Yesterday

Easy Apply

Contract

Depends on Experience

DATA Lead

Lares IT Solutions Inc

Remote • 14d ago

Easy Apply

Contract

70 - 80

Agentic AI Lead

KeyCorp

Remote • Today

Full-time

USD 116,000.00 - 216,000.00 per year

AI Solutions Architect Generative AI & Enterprise AI Strategy

Aroha Technologies

Remote or Arkansas • Today

Easy Apply

Full-time

Vice President, Global CAD Strategy & Sales

PTC

Remote • Today

Full-time

USD 375,000.00 - 506,000.00 per year

Director, Enterprise Architecture and Technology Strategy

Kyndryl

Remote or Pennsylvania • Today

Full-time

USD 179,760.00 - 341,520.00 per year

Data Strategy / Business Analyst Consultant

Vaco by Highspring

Remote • 8d ago

Easy Apply

Contract

$90

Job Details

Skills

Summary

Job Description:

We are seeking a Verification Lead to own the verification strategy for our medical device products and ensure that our software and systems meet their specified requirements and comply with applicable regulatory standards (FDA and notified body audits). This is a hands-on technical leadership role that bridges engineering, quality, and regulatory affairs. You will design verification protocols, drive risk-based test coverage, and mentor a team of verification engineers.

Key Responsibilities

Verification Strategy & Planning
- Author and maintain the Verification Plan (and associated Master V&V Plan) covering software, system, and subsystem verification activities.
- Define the verification approach in alignment with the IEC 62304 software development lifecycle, scaled to the product''s software safety classification (Class A/B/C).
- Establish verification scope, methods, acceptance criteria, entry/exit criteria, and resource and schedule estimates.
- Define and maintain requirements-to-test traceability, ensuring every requirement and risk control measure is verified.
Risk-Based Verification
- Integrate verification with the risk management process per ISO 14971, ensuring that risk control measures are verified for effectiveness and that residual risk acceptability is supported by objective evidence.
- Prioritize and scale test coverage according to risk, software safety class, and hazard analysis outputs.
- Verify that risk controls implemented in software are correctly traced, tested, and documented.
Test Protocol Design & Execution
- Design test protocols and test cases for unit, integration, software system, and overall system verification.
- Specify test environments, test data, tools, fixtures, and pass/fail criteria.
- Oversee protocol execution, review test records, and adjudicate anomalies and deviations.
- Manage the defect/anomaly lifecycle: triage, root cause support, regression strategy, and verification of fixes.
Reviews & Technical Governance
- Lead and facilitate design reviews, requirements reviews, test protocol reviews, and verification results reviews.
- Review verification deliverables for completeness, traceability, and audit-readiness.
- Serve as a gatekeeper at design milestones, providing objective verification evidence for design transfer and release decisions.
Documentation & Compliance
- Produce verification deliverables suitable for the Design History File (DHF) and regulatory submissions.
- Ensure compliance with IEC 62304, ISO 14971, ISO 13485, IEC 62366-1 (usability, where applicable), FDA 21 CFR 820 Design Controls, and EU MDR.
- Support internal and external audits, notified body assessments, and regulatory questions related to verification.
Leadership
- Mentor and provide technical direction to verification engineers.
- Coordinate cross-functionally with software development, systems engineering, quality, and regulatory affairs.
- Continuously improve verification methods, tooling, automation, and metrics.

Required Qualifications

Bachelor''s degree in engineering, computer science, or a related technical field (or equivalent experience).
8 years in verification, V&V, in medical devices.
Demonstrated working knowledge of IEC 62304 (software lifecycle and safety classification) and ISO 14971 (risk management).
Proficient in connected devices, embedded systems, or SaMD (Software as a Medical Device).
Experience authoring verification plans and designing test protocols from requirements.
Strong grasp of requirements traceability and design control processes.
Experience leading technical reviews and producing audit-ready documentation.
Excellent written communication; able to write protocols and reports that withstand regulatory review.
Experience supporting regulatory submissions and notified body audits.

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: saicon
Position Id: 26-74714
Posted 7 days ago

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Easy Apply

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Job Details

Skills

Summary

Job Description:

Key Responsibilities

Verification Strategy & Planning
- Author and maintain the Verification Plan (and associated Master V&V Plan) covering software, system, and subsystem verification activities.
- Define the verification approach in alignment with the IEC 62304 software development lifecycle, scaled to the product''s software safety classification (Class A/B/C).
- Establish verification scope, methods, acceptance criteria, entry/exit criteria, and resource and schedule estimates.
- Define and maintain requirements-to-test traceability, ensuring every requirement and risk control measure is verified.
Risk-Based Verification
- Integrate verification with the risk management process per ISO 14971, ensuring that risk control measures are verified for effectiveness and that residual risk acceptability is supported by objective evidence.
- Prioritize and scale test coverage according to risk, software safety class, and hazard analysis outputs.
- Verify that risk controls implemented in software are correctly traced, tested, and documented.
Test Protocol Design & Execution
- Design test protocols and test cases for unit, integration, software system, and overall system verification.
- Specify test environments, test data, tools, fixtures, and pass/fail criteria.
- Oversee protocol execution, review test records, and adjudicate anomalies and deviations.
- Manage the defect/anomaly lifecycle: triage, root cause support, regression strategy, and verification of fixes.
Reviews & Technical Governance
- Lead and facilitate design reviews, requirements reviews, test protocol reviews, and verification results reviews.
- Review verification deliverables for completeness, traceability, and audit-readiness.
- Serve as a gatekeeper at design milestones, providing objective verification evidence for design transfer and release decisions.
Documentation & Compliance
- Produce verification deliverables suitable for the Design History File (DHF) and regulatory submissions.
- Ensure compliance with IEC 62304, ISO 14971, ISO 13485, IEC 62366-1 (usability, where applicable), FDA 21 CFR 820 Design Controls, and EU MDR.
- Support internal and external audits, notified body assessments, and regulatory questions related to verification.
Leadership
- Mentor and provide technical direction to verification engineers.
- Coordinate cross-functionally with software development, systems engineering, quality, and regulatory affairs.
- Continuously improve verification methods, tooling, automation, and metrics.

Required Qualifications

Bachelor''s degree in engineering, computer science, or a related technical field (or equivalent experience).
8 years in verification, V&V, in medical devices.
Demonstrated working knowledge of IEC 62304 (software lifecycle and safety classification) and ISO 14971 (risk management).
Proficient in connected devices, embedded systems, or SaMD (Software as a Medical Device).
Experience authoring verification plans and designing test protocols from requirements.
Strong grasp of requirements traceability and design control processes.
Experience leading technical reviews and producing audit-ready documentation.
Excellent written communication; able to write protocols and reports that withstand regulatory review.
Experience supporting regulatory submissions and notified body audits.

Dice Id: saicon
Position Id: 26-74714
Posted 7 days ago

Fitment

Dice Job Match Score™

✨ Finding the perfect fit...

Create job alert

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

Similar Jobs

System Verification Engineer

Minneapolis, Minnesota

•

7d ago

Easy Apply

Contract, Third Party

Depends on Experience

Systems Engineer

Plymouth, Minnesota

•

Today

Easy Apply

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$50 - $55 /hr

Sr Chemist - Exempt

Medicine Lake, Minnesota

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7d ago

Easy Apply

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$40 - $50

Senior Systems Engineer

Saint Paul, Minnesota

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14d ago

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