Medline · 2 hours ago
Sr Engineer Risk Management
Mundelein, Illinois
Full-time
Hybrid
Mid, Senior Level
$92K/yr - $138K/yr
4+ years expMedline Industries is a global leader in the healthcare industry, and they are seeking a Senior Engineer for Risk Management. This role will be responsible for creating, monitoring, and enhancing risk controls for medical devices, cosmetics, and OTC drugs, collaborating with various departments to ensure compliance and effective risk mitigation.
Consumer GoodsHealth CareHospitalityManufacturingMedical
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 time lines for project completion
Qualification
Required
Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree
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
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
Masters of Science
Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field
At least 5 years of QA/QE experience in a cGMP Device or environment. Certification - Six Sigma certification
Working understanding of FDA, GMP, ISO 13485, and ISO 14971 - Experience facilitating FMEAs
Systems or clinical engineering experience
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (344)
2024 (144)
2023 (142)
2022 (143)
2021 (137)
2020 (113)
Funding
Current Stage
Public CompanyTotal Funding
$0.5MKey Investors
North Carolina Department of Commerce
2025-12-17IPO
2021-06-05Private Equity
2019-09-12Grant· $0.5M
Leadership Team
Steve Miller
Chief Operating Officer
Amanda Laabs
Chief Product Officer
Recent News
Packaging-Gateway.com
2026-01-16
2026-01-13
Company data provided by crunchbase