Sr Project Manager R&D

Medline Industries Inc.; United States; On-site; USD 101,000 - 152,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a leader to guide the development of medical devices, dietary supplements, cosmetics, and/or OTC/ANDA/NDA drugs. You will lead multifunctional teams across R&D, quality, regulatory, manufacturing, and product divisions as a subject matter expert in all phases of product development and portfolio oversight.

The role requires a Bachelor's degree, PMP certification, and 4+ years in medical device/pharma development with knowledge of design controls and 510k

Qualifications

• Bachelor's degree in Engineering or Science related field.
• PMP Certification.
• At least 4 years of experience in a medical device or pharmaceutical related field.
• 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).

Responsibilities

• Manage the product development process utilizing an iterative agile project management framework.
• 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.
• 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.
• Provide project and process 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.
• Keep current with regulatory guidelines, technical innovations, and new developments within the medical device or pharmaceutical industry.
• Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new test standards.

Skills

Project management

Regulatory knowledge

Risk assessment

Cross-functional leadership

Communication

Education

Bachelor's degree in Engineering or Science

Tools

Microsoft Project

Job description

Job Summary

The position will guide the development of medical devices, dietary supplements, cosmetics, and/or OTC/ANDA/NDA 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 an iterative agile project management framework.
• 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.
• 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.
• Provide project and process 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.
• Keep current with regulatory guidelines, technical innovations, and new developments within the medical device or pharmaceutical industry.
• Represent Medline on various ASTM/AAM/ISO technical committees and contribute to the development of new test standards.

Minimum Job Requirements

• Education: Bachelor's degree in Engineering or Science related field.
• Certification / Licensure: PMP Certification.
• Work Experience: At least 4 years of experience in a medical device or pharmaceutical related field. Experience in the development and launch of new medical/pharma products.
• Knowledge / Skills / Abilities: Project management Microsoft Project. 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).

Preferred Job Requirements

• Education: None
• Certification / Licensure: None
• Work Experience: None
• Knowledge / Skills / Abilities: None

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.

Salary

The anticipated salary range for this position: $101,000.00 - $152,000.00 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.

Equal Opportunity

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.

Company Information

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. If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you. 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. To learn more about how Medline makes healthcare run better, visit www.medline.com.