Sr. Engineer Risk Mgmt

Medline Industries, LP; Illinois; Hybrid; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a senior risk management lead to shape global risk controls for medical devices, cosmetics, and OTC drugs. You will analyze quality data, oversee major events, and ensure regulatory compliance across the product life cycle.

You will collaborate with clinical, design engineering, regulatory, labeling, and international partners to implement enhanced risk controls, enabling timely risk mitigation and transparent reporting.

Qualifications

• Bachelor-level science degree required; advanced degree preferred.
• Experience managing multiple quality projects in a regulated environment (FDA, GMP).
• Strong written and oral communication; ability to work independently and as part of a global team.

Responsibilities

• Create and align global risk management processes for consistent risk analysis.
• Evaluate risks and approve Change Controls, FMEA, MDR, Recalls, HHEs, and other major events.
• Communicate risks effectively to senior global management.
• Build relationships with quality and business partners across sites.
• Lead cross-department collaboration with R&D, Manufacturing and other sites globally.
• Create systems to analyze multiple data streams for health of quality/risk systems.
• Work with SMEs to develop a risk-based dashboard framework for real-time decision-making.
• Provide input on implementing risk controls and creating robust controls.
• Identify inefficiencies in Medline’s global quality management system and address them.
• Lead and ensure deadlines and goals are met and report progress.

Skills

Project management

Multitasking

Self-starter

Communication skills

Teamwork

Education

BS in Biology, Chemistry, Engineering or Statistics-based degree

MS in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or related field

Job description

Job Summary

This role will be the senior lead contributor within the organization that creates, monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure Medline is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs. This individual will collaborate with clinical, design engineering, regulatory, labeling, and international partners to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. Provide expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls to be compliant with EU MDR along with satisfying FDA, ISO 13485, and ISO 14971 risk management related processes throughout the product life cycle.

Job Description

MAJOR RESPONSIBILITIES:

• Create and align global risk management processes to ensure that risks are being analyzed consistently.
• Evaluate the risks and act as an approver for the following processes: Change Controls, Failure Mode Effect Analysis (FMEA), Medical Device Reporting (MDR), Recalls, Health Hazard Evaluations (HHEs), and other major quality events.
• Effectively communicate risks to senior global management.
• Build effective relationships with quality and business partners.
• Lead cross-department collaboration with R&D, Manufacturing, and other sites on a global level to ensure all risks are adequately addressed with robust risk controls.
• Create and manage systems to analyze multiple streams of data to gauge the health of a quality or risk management system.
• Work with Subject Matter Experts (SMEs) to create a framework for Risk-based dashboards to be used for real-time decision-making and management reporting.
• Provide detailed input to stakeholders on how to implement risk controls as well as create and implement controls.
• Identify inefficiencies in Medline’s global quality management system.
• Take action to address identified inefficiencies.
• Lead and ensure that deadlines and goals are being met.
• Frequently update management and team on progress.
• Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve timelines for project completion.

MINIMUM JOB REQUIREMENTS:

• Education: Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree.
• Work Experience: At least 4 years of QA/QE experience in a cGMP Device or environment.
• At least 2 years of direct risk management experience related to FDA regulated products.
• Experience creating quality sub-systems and leading complex projects.
• Knowledge / Skills / Abilities: Ability to manage 5+ projects at a time.
• Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner.

PREFERRED JOB REQUIREMENTS:

• Education: Masters of Science – Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field.
• Work Experience: At least 5 years of QA/QE experience in a cGMP Device or environment.
• Certification - Six Sigma certification.
• Knowledge / Skills / Abilities: Working understanding of FDA, GMP, ISO 13485, and ISO 14971.
• Experience facilitating FMEAs - Systems or clinical engineering experience.

The anticipated salary range for this position: $92,000.00 - $138,000.00 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.

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.

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.