Search Jobs | Dice.com

126 results (2 new)

Group by company

Lead Systems Engineer

Katalyst Healthcares and Lifesciences

Bothell, Washington • Today

Full-time

Lead Systems Engineer

University of Rochester

Remote • Today

Full-time

USD 97,400.00 - 146,000.00 per year

Lead Systems Engineer - Data Integration

Enterprise Holdings

Remote or St. Louis, Missouri • Today

Full-time

VDI End User Lead Systems Engineer III

Leidos

Remote or North Charleston, South Carolina • Today

Full-time

USD 87,100.00 - 157,450.00 per year

Lead Software Systems Engineer

Boeing Company

Kent, Washington • Today

Full-time

USD 158,100.00 - 213,900.00 per year

Systems Engineer - III (Risk and Compliance)

HonorVet Technologies

Kirkland, Washington • 13d ago

Easy Apply

Contract

$60 - $65

Lead IT Systems Engineer - Public Sector

Lumen

Remote or Maryland • Today

Full-time

USD 116,364.00 - 155,152.00 per year

Lead IT Systems Engineer - Public Sector

Lumen

Remote or Colorado • Today

Full-time

USD 111,074.00 - 148,099.00 per year

Lead DevSecOps Systems Engineer

General Dynamics

Remote • Today

Full-time

USD 212,500.00 - 287,500.00 per year

Lead Power Systems Engineer - Grid Integration and Stability, Consulting Services

GE Vernova

Remote • Today

Full-time

USD 89,300.00 - 148,700.00 per year

Senior Principal Systems Lead Engineer

General Dynamics

Remote or Indiana • Today

Full-time

USD 174,203.00 - 183,730.00 per year

Lead Mechanical Systems Design & Analysis Engineer

Boeing Company

Tukwila, Washington • Today

Full-time

USD 135,150.00 - 182,850.00 per year

Sr. Systems Engineer (2026-096)

Astronics Corporation

Kirkland, Washington • Today

Full-time

USD 102,687.00 - 154,031.00 per year

IT Systems Engineer IV

Robert Half

Lynnwood, Washington • Today

Easy Apply

Full-time

USD 150,000.00 - 180,000.00 per year

Senior Microsoft 365 Systems Engineer / Architect

Ledgent Technology

Remote • Today

Easy Apply

Contract

$65 - $75 per hour

Systems Engineer III

Apex Systems

Redmond, Washington • Today

Easy Apply

Full-time

$64 - $74 per hour

Senior AI Network Systems Engineer

Microsoft Corporation

Redmond, Washington • Today

Full-time

USD 119,800.00 - 234,700.00 per year

Control Systems Engineer III

Sigma Design

Kirkland, Washington • Today

Full-time

USD 120,000.00 - 170,000.00 per year

Senior Mission Systems Engineer

Boeing Company

Tukwila, Washington • Today

Full-time

USD 146,200.00 - 197,800.00 per year

Systems Engineer III

Amro Fabricating Corporation

Mukilteo, Washington • Today

Full-time

USD 110,000.00 - 140,000.00 per year

Systems Engineer, Lead

American Systems Corporation

Remote or Orlando, Florida • Today

Full-time

USD 150,000.00 per year

Sr. Software Systems Engineer (Everett, Washington (WA), US)

SPX

Everett, Washington • Today

Full-time

USD 165,200.00 - 300,000.00 per year

Sr Systems Engineer-Electrical Power Systems & Team Lead

Celestica International LP

Remote • Today

Full-time

USD 118,000.00 - 162,000.00 per year

Senior Systems Engineer, Kasten

Veeam Software Corporation

Remote • Today

Full-time

USD 202,000.00 - 375,100.00 per year

Systems Engineer IV - Cloud Engineering Lead

Leidos

Remote or North Charleston, South Carolina • Today

Full-time

USD 107,900.00 - 195,050.00 per year

Staff Systems Engineer, Temperature Calibration

Fortive

Everett, Washington • Today

Full-time

USD 157,780.00 - 263,465.00 per year

Lead Software Engineer, Distributed File Systems/Cloud Platform

Salesforce

Remote or San Francisco, California • Today

Full-time

USD 172,500.00 - 260,100.00 per year

Lead AI Engineer, Agentic and RAG Systems

EPAM Systems

Remote • Today

Full-time

Lead IT Systems Engineer - Public Sector

Lumen

Remote or Herndon, Virginia • Today

Full-time

USD 103,711.00 - 138,281.00 per year

Systems Engineer III - Containers (Remote)

First-Citizens Bank & Trust Company

Remote or Raleigh, North Carolina • Today

Full-time

USD 140,000.00 - 170,000.00 per year

Job Details

Skills

Documentation
Risk Management
Repair
Taxonomy
PASS
Offshoring
Reporting
Medical Devices
Design Controls
Inspection
System Requirements
Product Development
Verification And Validation
Fluency
ISO 9000
ISO 13485
Usability
FMEA
Supervision
Plant Lifecycle Management
Product Lifecycle Management
Application Lifecycle Management
Windchill
Design Review
Biomedicine
Mechanical Engineering
Electrical Engineering
Systems Engineering
Employment Authorization

Documentation
Risk Management
Repair
Taxonomy
PASS
Offshoring
Reporting
Medical Devices
Design Controls
Inspection
System Requirements
Product Development
Verification And Validation
Fluency
ISO 9000
ISO 13485
Usability
FMEA
Supervision
Plant Lifecycle Management
Product Lifecycle Management
Application Lifecycle Management
Windchill
Design Review
Biomedicine
Mechanical Engineering
Electrical Engineering
Systems Engineering
Employment Authorization

Summary

Job Description:
You will lead the remediation of design control records across a portfolio of released Class I and II medical devices, working onsite alongside the customer's systems engineering team. This is post-inspection remediation work. The requirements, risk and verification chain has gaps. You will find them, close them, and prove they are closed. This is not a documentation exercise. The engineering judgement is the job - deciding how deep a fix has to go and knowing when a record needs rebuilding rather than patching. You will own the technical standard for a small team, and you will be the person the customer escalates to.
Responsibilities:

Take ownership of assigned gap records across requirements, risk management and verification, and drive each one to a closed, approvable state.
Make the remediation depth call on every record - spot cleanup, targeted rework, or full reconstruction - and defend that call to the customer's systems engineering manager.
Repair and author requirements across the full product hierarchy, restoring upstream and downstream traceability that has been lost or never established.
Remediate Usability FMEA and design FMEA at product, element and part level, linking every risk control back to the requirement that implements it.
Assess and rebuild verification evidence where the existing record does not support the claim being made.
Build and own a failure-type taxonomy: classify each gap to a pattern, author the fix once, and propagate it across the portfolio rather than solving the same problem repeatedly.
Run a quality gate before anything reaches customer review. First-pass approval rate is the metric that protects the schedule.
Package work for an offshore support team, define acceptance criteria, and review everything they return before it is submitted.
Report weekly in one page: closed, in review, blocked, progress against plan. Same format every week.

Requirements:

8+ years in medical device systems engineering, with at least 3 years in design control remediation, design assurance or post-inspection response.
Defined and managed system requirements throughout the product development lifecycle, ensuring complete traceability from user needs to verification and validation.
Worked a live FDA 483 or warning letter remediation and can describe what you personally closed.
Fluent in ISO 14971, ISO 13485, and 21 CFR 820.30
Decompose requirements, author DFMEA and Usability FMEA, and design verification protocols without supervision.
Worked in a PLM and an ALM environment. Windchill, Codebeamer are the toolchain here; equivalents are acceptable with a short ramp.
You hold your position in a room. You will be the senior Client's engineer in a customer design review, and you will be asked to justify decisions on the spot.
Bachelor's or Master's in biomedical, mechanical, electrical or systems engineering.
US work authorization and can be onsite in Bothell three days a week.

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: 3c15f4990c113dda919f26b2b8cd
Posted 1 day 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

Product Design Quality Engineer

Bothell, Washington

•

Today

Job Description: The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requirements, quality standards, and design control processes. This role partners with cross-functional teams to integrate quality into product development, risk management, validation, and manufacturing transfer activities. Responsibilities: Support Design Control activities throughout the product development lifecycle in

Full-time

Senior Design Quality Engineer Medical Devices | Design Controls & Risk Management | Contract | Onsite - Bothell, WA / Cambridge, MA| $55/hr on C2C

Bothell, Washington

•

5d ago

Senior Design Quality Engineer Medical Devices | Design Controls & Risk ManagementOnsite Location: Bothell, WA / Cambridge, MA Job Type: Contract Job OverviewWe are seeking an experienced Senior Design Quality Engineer / Design Assurance Engineer with strong experience in FDA-regulated medical device environments. The ideal candidate will have hands-on experience with Design Controls, Design Verification & Validation, Risk Management, CAPA, Change Control, Design Transfer, and Quality Management

Easy Apply

Contract

Depends on Experience

Staff Engineer, R&D

No location provided

•

Today

Job Description Support the design and manufacture of medical devices, including creating 3-D designs using a design software such as SolidWorks, generating detailed 2-D drawings, writing engineering requirements, developing test methods, designing test fixtures, supporting product manufacturing, and solving issues through design, development, design transfer launch, and post market phases. Work closely with R&D counterparts, Operations, Quality, and Regulatory in supporting the development of

Full-time

USD 116,706.00 - 151,176.00 per year

Lead Software Engineer

Bellevue, Washington

•

6d ago

About Us Visa is a world leader in payments technology, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and territories, dedicated to uplifting everyone, everywhere by being the best way to pay and be paid. At Visa, you'll have the opportunity to create impact at scale - tackling meaningful challenges, growing your skills and seeing your contributions impact lives around the world. Join Visa and do work that

Full-time

USD 173,100.00 - 276,800.00 per year

Job Details

Skills

Documentation
Risk Management
Repair
Taxonomy
PASS
Offshoring
Reporting
Medical Devices
Design Controls
Inspection
System Requirements
Product Development
Verification And Validation
Fluency
ISO 9000
ISO 13485
Usability
FMEA
Supervision
Plant Lifecycle Management
Product Lifecycle Management
Application Lifecycle Management
Windchill
Design Review
Biomedicine
Mechanical Engineering
Electrical Engineering
Systems Engineering
Employment Authorization

Documentation
Risk Management
Repair
Taxonomy
PASS
Offshoring
Reporting
Medical Devices
Design Controls
Inspection
System Requirements
Product Development
Verification And Validation
Fluency
ISO 9000
ISO 13485
Usability
FMEA
Supervision
Plant Lifecycle Management
Product Lifecycle Management
Application Lifecycle Management
Windchill
Design Review
Biomedicine
Mechanical Engineering
Electrical Engineering
Systems Engineering
Employment Authorization

Summary

Take ownership of assigned gap records across requirements, risk management and verification, and drive each one to a closed, approvable state.
Make the remediation depth call on every record - spot cleanup, targeted rework, or full reconstruction - and defend that call to the customer's systems engineering manager.
Repair and author requirements across the full product hierarchy, restoring upstream and downstream traceability that has been lost or never established.
Remediate Usability FMEA and design FMEA at product, element and part level, linking every risk control back to the requirement that implements it.
Assess and rebuild verification evidence where the existing record does not support the claim being made.
Build and own a failure-type taxonomy: classify each gap to a pattern, author the fix once, and propagate it across the portfolio rather than solving the same problem repeatedly.
Run a quality gate before anything reaches customer review. First-pass approval rate is the metric that protects the schedule.
Package work for an offshore support team, define acceptance criteria, and review everything they return before it is submitted.
Report weekly in one page: closed, in review, blocked, progress against plan. Same format every week.

Requirements:

8+ years in medical device systems engineering, with at least 3 years in design control remediation, design assurance or post-inspection response.
Defined and managed system requirements throughout the product development lifecycle, ensuring complete traceability from user needs to verification and validation.
Worked a live FDA 483 or warning letter remediation and can describe what you personally closed.
Fluent in ISO 14971, ISO 13485, and 21 CFR 820.30
Decompose requirements, author DFMEA and Usability FMEA, and design verification protocols without supervision.
Worked in a PLM and an ALM environment. Windchill, Codebeamer are the toolchain here; equivalents are acceptable with a short ramp.
You hold your position in a room. You will be the senior Client's engineer in a customer design review, and you will be asked to justify decisions on the spot.
Bachelor's or Master's in biomedical, mechanical, electrical or systems engineering.
US work authorization and can be onsite in Bothell three days a week.

Dice Id: 91116760
Position Id: 3c15f4990c113dda919f26b2b8cd
Posted 1 day 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

Product Design Quality Engineer

Bothell, Washington

•

Today

Full-time

Senior Design Quality Engineer Medical Devices | Design Controls & Risk Management | Contract | Onsite - Bothell, WA / Cambridge, MA| $55/hr on C2C

Bothell, Washington

•

5d ago

Easy Apply

Contract

Depends on Experience

Staff Engineer, R&D

No location provided

•

Today

Full-time

USD 116,706.00 - 151,176.00 per year

Lead Software Engineer

Bellevue, Washington

•

6d ago

Full-time

USD 173,100.00 - 276,800.00 per year