Manager Research and Development, Design Assurance

Medline Industries, LP•Northfield, IL

1d•$134,000 - $201,000•Onsite

About The Position

Manage Research and Development (R&D) function and resources to include: employees, project management, stability or other research related functional areas in support of Medline product development.

Requirements

Bachelor’s degree in Chemistry, Biology or related science field.
A least 4 years of experience in a medical device or pharmaceutical related field.
Experience in the indirect management of team members, including assisting in the development, training and assignment of work/projects to other members of a team.
Experience assessing and initiating actions independently.
Experience taking charge of a situation, team or project.
Experience processing all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.
Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.

Nice To Haves

Minimum of 7 years of experience in medical device design controls, design assurance, quality engineering, or related regulatory roles.
Demonstrated experience leading or governing Design History Files (DHF) for Class I and Class II medical devices.
At least 3 years of proven people management experience (direct reports)
Experience participating in or leading DHF remediation or CAPA-driven d
Strong working knowledge of FDA 21 CFR 820.30, ISO 13485, and ISO 14971.
Experience supporting FDA inspections, notified body audits, or internal audits related to design controls.
Demonstrated ability to evaluate design control documentation quality—not just presence—and ensure traceability across DHF elements.
Experience operating in complex, matrixed organizations with multiple product lines and divisions

Responsibilities

Manage the activities and accountability of a team to ensure that deadlines and project goals are met.
Contribute to resource planning based on evolving organizational needs.
Collaborate with divisional personnel, quality, regulatory, legal, and manufacturers to identify projects and new product initiatives, develop timelines, identify necessary resources, and establish clear lines of communication to ensure successful execution.
Identify issues and risks that might delay a project and make recommendations or develop contingency plans.
Evaluate new technologies and products.
Remain up-to-date with new developments in the field, nationally and internationally, and incorporate as required.
Research, plan, and implement new products, programs, and/or protocols.
Day-to-day operations of a group of employees.
May have limited budgetary responsibility and usually contributes to budgetary impact; Interpret and execute policies for departments/projects and develops.
Recommend and implement new policies or modifications to existing policies.
Provide general guidelines and parameters for staff functioning.
Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.