Sr Project Manager - Quality

Medline Industries, LP; United States; On-site; USD 92,000 - 138,000; Full time

Job summary

Medline Industries, LP is seeking a Senior Project Manager to guide the development of medical devices, dietary supplements, cosmetics, and OTC drugs. You will lead cross-functional teams across R&D, quality, regulatory, manufacturing, and product divisions to deliver on strategic initiatives.

The role emphasizes portfolio management, planning, budgeting, and keeping projects on schedule, with a focus on design controls, risk assessments, and the 510(k) process. Travel up to 10% may be required.

Qualifications

• Education: Bachelor's degree in Engineering or Science related field.
• Certification: PMP Certification.
• Experience: At least 4 years in a medical device, pharmaceutical, dietary supplement or cosmetic related field.
• Experience: At least 2 years of project management experience.
• Experience with development and launch of new medical/pharma/dietary supplement/cosmetic products.
• Knowledge of medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.
• Travel up to 10% of the time (domestic and international).

Responsibilities

• Guide the development of medical devices, dietary supplements, cosmetics, and OTC drugs.
• Lead cross-functional teams across R&D, quality, regulatory, manufacturing, and product divisions.
• Manage project plans, budgets, scope, timelines, and projected end dates.
• Develop risk assessments and contingency plans to mitigate delays or cost overruns.
• Ensure alignment with divisional strategies and milestones.
• Coach junior staff and provide status updates to leadership.

Skills

Project management

Agile methodologies

Risk assessments

Education

Bachelor's degree in Engineering or Science related field

PMP Certification

Job description

Job Summary

The position will guide the development of medical devices, dietary supplements, cosmetics, and/or OTC drugs. Lead collaborative, multifunctional teams consisting of R&D personnel, quality, regulatory, manufacturing, and product divisions. Will serve as a subject matter expert on all phases of product development and is responsible for managing and overseeing all aspects of a project portfolio spanning multiple priorities and functional areas.

Job Description MAJOR RESPONSIBILITIES

Manage the product development process utilizing various project management frameworks such as iterative agile. Manage project portfolios and ensure that project and divisional goals are aligned. Provide updates to and advise divisional leadership on project status and opportunities. Collaborate with product divisions to compile strategic plans, establish innovation pipelines, and align product development efforts with long-term divisional strategies. Manage assigned projects, balance corporate priorities, and ensure team alignment across functional areas to ensure that project deadlines and goals are met. Develop, communicate, and track project plans, objectives, budgets, scope, timelines, and projected end dates. Translate project goals into project tasks. Leader in the use and application Medline's Project Management Portal to execute projects effectively. Leverage lessons learned to conduct risk assessments and identify issues that may cause project delays or cost overruns. Develop and implement contingency plans to mitigate the impact. Compile risk profiles associated with scope creep and changing project requirements. Maintain team morale and engagement by ensuring constant and transparent communication. Generate team consensus. Lead project and process best practice guidance to cross-functions team members. Supervise, coach, and train junior staff. Compile technical justifications and data summaries in support of product claims. Lead process improvement initiatives or additional quality initiatives as project manager. Keep current with regulatory guidelines, technical innovations, and new developments within the medical device or pharmaceutical industry.

MINIMUM JOB REQUIREMENTS

Education: Bachelor's degree in Engineering or Science related field. Licensure/Certification: PMP Certification Work Experience: At least 4 years of experience in a medical device, pharmaceutical, dietary supplement or cosmetic related field. At least 2 years of project management experience. Experience in the development and launch of new medical/pharma/dietary supplement/cosmetic products. Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process. Knowledge / Skills / Abilities: Project management tools and techniques. Knowledge of medical device requirements (Class I-II), design controls, risk assessments, and the 510k process. Position may require travel up to 10% of the time for business purposes (domestic and international).

DISCLAIMER

All duties and requirements are subject to possible modification to reasonably accommodate individuals with disabilities. This position description in no way states or implies that these are the only duties to be performed by an employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor(s)/manager(s). This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.

Compensation

The anticipated salary range for this position: $92,000.00 - $138,000.00 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.

Benefits

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.

Company Culture

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. 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. Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time.

About Medline

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories.