Senior R&D Project Manager — Medical Devices & Pharma

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

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