Job Description
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:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
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. Explore our Belonging page here.
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.
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:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
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. Explore our Belonging page here.
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.
About Medline Industries
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its unique offering of world-class products, supply chain resilience and clinical practice expertise, Medline delivers improved clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs 43,000 people worldwide and operates in over 100 countries and territories.
It has always been Medline's intention and purpose to create a great place to work for everyone. We believe tapping into the richness of our employees' diversity allows us to find innovative solutions for our customers, who themselves represent a diverse group both in the U.S. and around the world. The Belonging and Engagement team at Medline is dedicated to fostering an inclusive and supportive workplace culture. We focus on creating opportunities for employees to feel seen, supported, and connected through initiatives like Employee Resource Groups (ERGs), cultural awareness events, new hire engagement, and leadership training.
Every hour of every day, healthcare professionals rely on Medline to help them do their job. Our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you're a self-starter, eager to grow your career within a high-performing environment, this is the place for you. Together, we make healthcare run better.
For more on all things Belonging at Medline Industries, check out our home page here.
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