Job Summary
The Sr. Design Assurance Engineer provides critical oversight and governance of our Design History Files (DHF) to ensure compliance with regulatory standards and internal quality requirements. This role is essential for guiding and approving design controls, facilitating design transfer, and managing risk files. It ensures that all processes and documentation meet the high standards appropriate for our various product lines, including Class I, and Class II 510k devices. The Design Assurance Engineer ensures that our products are developed and transferred to manufacturing with the highest level of quality and regulatory compliance, and ensuring design changes are appropriately documented and kept current.Job Description
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.
Supports R&D/QA/RA teams in new product development and remediation activities, including the following:
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.
Qualifications:
Bachelor's degree in biomedical engineering, mechanical engineering, electrical engineering, or equivalent.
At least four years of experience in Design History File creation and oversight.
Preferred Qualifications:
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
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:
$96,200.00 - $144,560.00 AnnualThe 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 a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.