Sr Engineer Software Validation

Medline; United States; Remote; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline is seeking a leadership-level professional to guide validation projects, ensuring compliance with customer and regulatory expectations. You will design and execute validation strategies across software, processes, and facilities, coordinating with multiple teams and stakeholders to meet project goals.

The role requires deep experience with GAMP 5, FDA 21 CFR Part 820, ISO 13485, and medical device QMS environments, plus strong communication and project-management skills.

Qualifications

• 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.
• Direct experience in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and Software Validation principles.
• Knowledge of software engineering concepts and ability to lead cross-functional teams.
• Experience with project management and cross-functional collaboration.
• Experience operating in an AS400 environment.
• Travel up to 25% for business purposes.

Responsibilities

• Lead design, development, and execution of software validation plans and tests.
• Manage multiple validation projects and communicate status to customers.
• Document validation protocols and reports with professional written communication.
• Adhere to Medline policies and relevant regulatory procedures.
• Support on-site facilities and drive process improvements in validation workflows.

Skills

Software validation

Regulatory compliance

Project management

AS/400 experience

MS Word

MS Project

MS Excel

Kanban

Communication

Education

Bachelor's degree in Engineering / Quality / Business / Computer Science

Tools

MS Word

MS Project

MS Excel

Job description

Job Summary

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.

Job Description

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.

Minimum Job Requirements

• 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 Principles of Software Validation, Electronic Records/Signatures.


• Knowledge / Skills / Abilities: Experience applying knowledge of standard concepts, practices, and procedures within software engineering.


• Experience with 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).

Preferred Job Requirements

• 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.

Benefits & Compensation

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.

Medline Industries, LP and its subsidiaries offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

Company Culture

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.

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time.

If you're a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

Equal Opportunity Statement

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.

Company Information

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes.

Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories.

To learn more about how Medline makes healthcare run better, visit www.medline.com.