Senior Project Manager

Medline; Northfield Township (IL); On-site; USD 90,000 - 150,000; Full time

Job summary

Medline is seeking a seasoned Project Manager to guide the development of medical devices, dietary supplements, cosmetics, and OTC drugs. You will lead multifunctional teams across R&D, quality, regulatory, manufacturing, and product divisions, serving as a subject matter expert throughout all phases of product development.

You will manage portfolios, apply agile frameworks, keep leadership informed on status and risks, and drive process improvements while ensuring regulatory compliance and

Qualifications

• Bachelor's degree in Engineering or Science related field.
• PMP Certification.
• Minimum 4 years in medical device/pharma/cosmetic field.
• At least 2 years of project management experience.
• Experience with medical device development, 510(k) process, design controls, risk assessments.

Responsibilities

• Lead cross-functional teams across R&D, quality, regulatory, manufacturing, and product divisions.
• Manage product development processes using agile frameworks.
• Align project portfolios with divisional goals.
• Provide updates to divisional leadership on project status.
• Develop and track project plans, budgets, scopes, and timelines.
• Lead process improvement and quality initiatives as PM.

Skills

Project management

Regulatory knowledge

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Tools

Medline's Project Management Portal

Job description

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.

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).