Sr Engineer Software Validation

Medline; Redmond (OR); On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks an experienced leader to drive validation programs ensuring FDA, ISO, and GAMP requirements are met. You will lead development and execution of validation projects across software, process, and facility domains.

You will design test strategies, coordinate multiple projects, and document validation protocols while maintaining Medline policies and quality records. The role supports regulatory compliance and continuous improvement in a global medical device environment.

Qualifications

• Bachelor's degree in Engineering, Quality, Business, or Computer Science.
• 5+ years of experience in Manufacturing, Quality or Engineering.
• 3+ years in GAMP 5 validated computerized systems.
• Experience in FDA 21 CFR Part 820, ISO 13485, ISO 14971 and software validation principles.
• Experience leading cross-functional teams and project management.
• Knowledge of QMS and ISO13485:2016, 21 CFR 11, and audits.

Responsibilities

• Evaluate systems and applications to design validated software, processes, and related validations.
• Design, develop, and implement test strategies, plans, scripts, and procedures.
• Coordinate, execute, and report on validation plans for software.
• Manage multiple validation projects and communicate status to customers.
• Document validation protocols and reports with professional writing.
• Support Medline policies and regulatory procedures.
• Maintain awareness of FDA, GAMP, ISO regulatory environment.
• Improve efficiencies in software validation and related processes.
• Support development and upkeep of Divisional SOPs for software use.
• Provide system design feedback to ensure regulatory compliance throughout SDLC.

Skills

Leadership

Project management

Regulatory knowledge

Documentation

Education

Bachelor's degree in Engineering, Quality, Business, or 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.

Major 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.
• Coordinate, Execute, and Report on validation plans for custom and off-the shelf software.
• 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 development and upkeep of Divisional SOPs as related to software use.
• Provide system design feedback to ensure compliance with regulatory and Medline standards throughout the software development life cycle.

Minimum Job Requirements

• Education: Bachelor's degree in Engineering, Quality, Business, or Computer Science.
• Work Experience: 5+ years of experience in Manufacturing, Quality or Engineering.
• 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.
• Additional 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).

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.
• 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, 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.

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.

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.

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.