Job Description

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.

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. Management responsibilities include:
• 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.

Qualifications:

• 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.

Preferred Qualifications:

• 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

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:

$134,000.00 - $201,000.00 Annual

The 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here

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.