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Planet Pharma · 10 hours ago

R&D Project Management Specialist III

Irvine, CA

Full-time

Onsite

Senior Level

$65/hr - $75/hr

Planet Pharma is a company focused on the rapid development of life-saving medical technology. They are seeking an R&D Project Management Specialist to lead New Product Development from feasibility to commercial launch, ensuring compliance and effective communication across teams.

BiotechnologyHealth CarePharmaceutical

Hiring Manager

Patrick Sazama

Responsibilities

End-to-End NPD Leadership: Directly manage the R&D lifecycle for patient medical devices (e.g., billing devices, catheters) from early-stage feasibility to market launch

Stakeholder Communication: Conduct monthly project reviews with the leadership team; deliver polished, high-level presentations on project status, risks, and milestones

Technical Team Management: Act as the "translator" and driver for R&D engineers. You will manage schedules, identify technical risks, and ensure the team stays on an aggressive timeline without needing to be the technical lead yourself

Process Rigor: Execute daily activities within Change Control and Design Control, ensuring 100% compliance with Medical Device regulations

Cross-Functional Influence: Build strong relationships across a matrixed environment to secure resources and maintain momentum

Qualification

NPD Medical Device ExperienceMS ProjectAgile/ScrumClass I/II devices knowledgeChange ControlDesign ControlResilienceBachelor's DegreePMP CertificationAgile CertificationScrum Master CertificationPolished PresentationProactive OwnershipHigh Emotional Intelligence

Required

NPD Medical Device Experience (Non-Negotiable): You must have direct experience managing New Product Development specifically for patient medical devices. Experience in Operations/Manufacturing or General IT PMO will not be considered for this role

R&D Focused: Proven track record of working directly with R&D teams to develop new hardware/disposable products (Software, Firmware, and Thermoplastic Hardware experience is a plus)

The 'Language' of Engineering: While an Engineering degree is preferred, you must be able to demonstrate the ability to manage and command the respect of technical engineers in an R&D environment

Tool Proficiency: Expert-level skills in MS Project and experience working within Agile/Scrum methodologies (preferred for our development process)

Industry Knowledge: Deep understanding of Class I/II devices, Change Control, and Design Control. We are looking for someone who can hit the ground running with industry standards on Day 1

Bachelor's Degree: Required (Mechanical, Biomedical, or Electrical Engineering preferred)