Medline · 1 day ago
Sr Engineer Software Validation
Northfield, IL
Full-time
Onsite
Senior Level
$101K/yr - $152K/yr
5+ years expMedline is a growing worldwide organization that offers a competitive total rewards package and continuing education. They are seeking a Senior Engineer for Software Validation to lead the development and execution of validation projects, ensuring customer and regulatory requirements are met in a timely manner.
HospitalityConsumer GoodsHealthcareManufacturingHealth CareMedical
Responsibilities
Evaluate systems and applications to properly design organized and efficient software, process, automation, cleaning, facility, and utility system related validations
Ensure scope and complexity of validations are commensurate with risk including the design, development, and implementation of test strategy, plans, scripts, and test procedures to meet requirements
Manage multiple, concurrent validation projects, including gathering and understanding customer requirements and effectively communicating project status to keep customer informed and satisfied
Document validation protocols and reports with professional and technical written communication skills
Know, support, and conform to Medline policies and relevant governing procedures
Maintain awareness to industry and regulatory environment, including FDA, GAMP, ISO
Maintain organizational excellence, including document control, quality records, detail, and thoroughness
Evaluate ways to streamline and improve efficiencies in software validation and associated processes
Provide team support in all validation initiatives as requested. Support division facilities on-site when needed
Qualification
Required
Bachelor's degree in Engineering, Quality, Business, or Computer Science
At least 5 years of experience in Manufacturing, Quality or Engineering
At least 3 years of experience in GAMP 5 related computerized system validations, including designing, authoring, executing, and coordinating
Direct experience operating in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principals of Software Validation, Electronic Records/Signatures
Applying knowledge of standard concepts, practices, and procedures within software engineering
Experience and skills in influencing, leading and directing individuals in multiple functional areas
Experience with project management (for example: planning, organizing, and managing resources to bring about the successful completion of specific project goals and objectives)
Experience working in an AS400 environment
Preferred
Experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.)
Experience with QMS – ISO13485:2016 - 21 CFR 820 QSR, 21 CFR Part 11 Electronic Signature, 21 CFR 801 Labeling
Experience with GAMP Good Practice Guide: IT Infrastructure Control and Compliance (GAMP 5) ISO / Customer / Regulator Audits
Experience with FDA Product and Establishment Registration
Experience with GS1 / GUDID Management
Quality Management System / Medical device environment experience
Proficient in MS Word, Project, Excel
Experience in people and process management
Continuous improvement and Kanban related project experience
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (344)
2024 (144)
2023 (142)
2022 (143)
2021 (137)
2020 (113)
Funding
Current Stage
Public CompanyTotal Funding
$0.5MKey Investors
North Carolina Department of Commerce
2025-12-17IPO
2021-06-05Private Equity
2019-09-12Grant· $0.5M
Leadership Team
Steve Miller
Chief Operating Officer
Amanda Laabs
Chief Product Officer
Recent News
Packaging-Gateway.com
2026-01-16
2026-01-13
Company data provided by crunchbase