Sr Engineer Software Validation (Medical Device)

Location: Remote in Illinois, United States; travel up to 25% within and outside the state, with on-site support for division facilities when needed.

Salary: $101,000–$152,000 annual; bonus and/or incentive eligible.

Company

hirify.global is a growing worldwide medical device organization providing regulated healthcare products and services.

What you will do

• Evaluate systems and applications and design software, process, automation, cleaning, facility, and utility system validations.
• Develop and implement risk-based validation strategies, plans, scripts, protocols, and test procedures.
• Manage multiple concurrent validation projects, gather customer requirements, and communicate project status.
• Prepare validation protocols and reports using professional technical documentation.
• Maintain compliance with hirify.global procedures, FDA, GAMP, ISO, document-control, and quality-record requirements.
• Improve software validation efficiency and support validation initiatives and division facilities as needed.

Requirements

• 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 with GAMP 5 computerized system validations, including designing, authoring, executing, and coordinating validations.
• Direct experience in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principles of Software Validation, and electronic records/signatures.
• Experience applying standard software engineering concepts, practices, and procedures.
• Experience influencing, leading, and directing individuals across multiple functional areas.
• Experience planning, organizing, and managing resources for project completion.
• Experience working in an AS400 environment.
• Availability to travel up to 25% for business purposes, within and outside the state.

Nice to have

• Experience in Manufacturing, Quality, or Engineering covering four major validation subjects, such as computer, equipment, cleaning, and process validation.
• Experience with ISO 13485:2016, 21 CFR 820 QSR, 21 CFR Part 11, 21 CFR 801 labeling, GAMP 5 IT infrastructure control and compliance, ISO/customer/regulator audits, FDA product and establishment registration, GS1, and GUDID management.
• Quality management system and medical device environment experience.
• Proficiency in Microsoft Word, Project, and Excel.
• Experience in people and process management.
• Continuous improvement and Kanban project experience.

Culture & Benefits

• Full-time employment with health insurance, life and disability coverage, 401(k) contributions, and paid time off for employees working at least 30 hours per week on average.
• Employees working fewer than 30 hours per week receive 401(k) contributions, paid time off, and access to an Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.
• Competitive total rewards, continuing education, and training opportunities.
• Inclusive workplace focused on belonging, diversity, and career growth.