What are the responsibilities and job description for the Research and Development Project Manager position at ALOIS Solutions?
🚨 Hiring: Project Manager – R&D | Medical Device NPD
📍 San Clemente, CA (Hybrid)
💲 Competitive Pay | Long-Term Opportunity
We are actively seeking an experienced R&D Project Manager with a strong background in Medical Device New Product Development (NPD) to support enterprise-level R&D initiatives within a highly regulated healthcare environment.
The ideal candidate will have hands-on experience driving products through the full medical device development lifecycle — from design inputs and verification/validation through regulatory submission and product launch.
🔹 What We’re Looking For:
✔ Strong Medical Device NPD experience
✔ Deep understanding of Design Controls
✔ Experience supporting FDA 510(k), MDR, and regulatory submissions
✔ Ability to work in fast-paced, ambiguous R&D environments
✔ Proven success driving cross-functional alignment across R&D, Regulatory, Quality, Operations, and Supply Chain
✔ Experience supporting product launch and sustaining engineering activities
🔹 Key Responsibilities:
• Lead complex R&D and New Product Development programs in FDA-regulated environments
• Drive project execution from concept through commercialization
• Manage project schedules, budgets, resources, risks, and deliverables
• Coordinate cross-functional teams including Regulatory Affairs, Quality, Manufacturing, Operations, Marketing, and Supply Chain
• Support design control activities including product performance, assembly integrity, product safety, labeling, packaging, and verification/validation efforts
• Partner with stakeholders to define project scope, validation strategy, and requirements in evolving development environments
• Ensure projects remain compliant with FDA, ISO 13485, GMP, and MDR requirements
• Provide executive-level status reporting and project communication
🔹 Required Qualifications:
• Bachelor’s degree required
• 4 years of Project Management experience within Medical Devices or regulated healthcare industries
• Experience with Design Controls and Medical Device Development Lifecycle
• Strong understanding of NPD processes and regulatory requirements
• Proficiency with MS Project, Excel, PowerPoint, SharePoint, and related PM tools
This is an excellent opportunity for someone who thrives in early-stage product development environments and can independently drive execution across multiple teams.
📩 Interested candidates can apply directly or send resumes for immediate consideration.