New · posted Oct 28
Medline · Medical Devices
Sr Engineer Software Validation
- Remote, Illinois
- Remote
- Full-time
- Senior & Principal
The role
Deliver leadership-level role in the development and execution of validation projects, ensuring customer and regulatory requirements are met in a timely and satisfactory manner.
What you need
Education
- Bachelor’s degree in Engineering, Quality, Business, or Computer Science.
Work Experience
- 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.
Knowledge / Skills / Abilities
- Experience 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.
- Position requires travel up to 25% of the time for business purposes (within state and out of state).
Work Experience
- Experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.).
- Experience with the following:
- QMS – ISO13485:2016
- 21 CFR 820 QSR, 21 CFR Part 11 Electronic Signature, 21 CFR 801 Labeling
- GAMP Good Practice Guide: IT Infrastructure Control and Compliance (GAMP 5)
- ISO / Customer / Regulator Audits
- FDA Product and Establishment Registration
- GS1 / GUDID Management
- Quality Management System / Medical device environment experience.
Knowledge / Skills / Abilities
- Proficient in MS Word, Project, Excel.
- Experience in people and process management.
- Continuous improvement and Kanban related project experience
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$101,000.00 - $152,000.00 Annual
The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
What you'll do
- 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.
Pay and benefits
$101,000 – $152,000 a year
Employer providedHealth insurance
Life and disability insurance
401(k) contributions
Paid time off
Bonus/incentive eligible
Continuing education & training
Equal opportunity, accessibility and legal noticesMedline's statements, word for word
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Senior & Principal roles in Illinois6 roles publishing pay
Senior & Principal roles in the US56 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $101,000 | — | $152,000 |
| Illinois (middle half) | $114,250 | $119,250 | $125,750 |
| All US (middle half) | $105,375 | $121,000 | $132,250 |
This role: Medline's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 123 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Medline's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 37 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification10
- Data and digital systems9
- Documentation and SOPs6
- Collaboration and leadership5
- GMP and compliance4
- Quality systems and risk4
- Lab testing and methods1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
Medline on Regulatory Jobs
- 58
- Open roles
- 42
- Distinct roles
- 23
- Locations
By discipline
- Quality51 88%
- Regulatory6 10%
- Compliance & Safety1 2%
By level
- Associate & Specialist39 67%
- Senior & Principal12 21%
- Director3 5%
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Sr Engineer Software Validation at Medline
Open until filled. $101K–$152K a year, employer provided.