Sr Project Manager R&D

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/AAMI/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. Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process.

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).