Medline Industries, LP · 1 day ago
Sr Engineer Design Assurance
Northfield, IL
Full-time
Onsite
Mid, Senior Level
$92K/yr - $138K/yr
2+ years expMedline is a company focused on providing critical oversight and governance in the medical device industry. They are seeking a Senior Design Assurance Engineer to ensure compliance with regulatory standards and internal quality requirements for their Design History Files, guiding design controls and managing risk files.
Consumer GoodsHealth CareHospitalityManufacturingMedical
Responsibilities
Oversee the creation, maintenance, and review of DHFs to ensure completeness, accuracy, and compliance with regulatory standards. Ensure that all DHF documentation is up-to-date and reflects the current design and development status of the product
Provide guidance and approval for design control documents, ensuring that all design inputs, outputs, verifications, validations, and changes are properly documented and meet regulatory requirements
Collaborate with cross-functional teams to ensure design control activities are integrated into the product development lifecycle
Sign off on appropriate design control files as independent reviewer as needed
Review and govern the design transfer process, ensuring documentation and knowledge from development to manufacturing is accurately communicated and documented and comply with Medline’s procedures and any applicable regulatory requirements
Contribute to the assembly, maintenance, and tracking of Design History Files, ensuring they are appropriately managed and consistently filed in our QMS system across the organization, facilitating easy location by SKU/DMR
Ensure our DHF procedures are relevant, thorough, unambiguous. Provide guidance and training to the Medline R&D and Quality team regarding DHF procedures and best practices
Provide governance on design change process and documentation, ensuring design changes are accurately documented comply with Medline’s procedures
Qualification
Required
Bachelor's degree in biomedical engineering, mechanical engineering, electrical engineering, or equivalent
At least two years of experience in Design History File creation and oversight
Preferred
Experience in product design within the medical device industry
Experience with medical device requirements (Class I-II), 510k process, design controls, design change, design transfer, and assessment of risk
Benefits
Health insurance
Life and disability
401(k) contributions
Paid time off
Company
Medline Industries, LP
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
10001+ employees
H1B Sponsorship
Medline Industries, LP 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
2026-01-07
2025-12-26
TheStreet.com
2025-12-20
Company data provided by crunchbase