Senior Medical Device R&D Project Leader (Hybrid)

Weekday AI; San Clemente; Hybrid; PHP 7,561,000 - 11,342,000; Full time

Job summary

Weekday is seeking a Senior Project Manager – R&D with deep expertise in Medical Device New Product Development (NPD) to lead enterprise-level, FDA-regulated R&D initiatives. Based in San Clemente, CA, the role is hybrid, overseeing design controls, regulatory submissions, and product launches.

You will drive cross-functional collaboration across R&D, Regulatory, Quality, Operations, and Supply Chain to ensure timely, compliant project delivery from concept to launch.

Qualifications

• Bachelor’s degree required in a relevant field.
• Minimum 4 years of PM experience in Medical Device or regulated healthcare.
• Experience with Design Controls and Medical Device Development Lifecycle.
• Strong MS Project, Excel, PowerPoint, and SharePoint skills.

Responsibilities

• Lead complex R&D and New Product Development initiatives within FDA-regulated contexts.
• Oversee projects from initial concept through to commercialization.
• Manage schedules, budgets, resources, risks, and deliverables.
• Coordinate multidisciplinary teams such as Regulatory Affairs, Quality, Manufacturing, Operations, Marketing, and Supply Chain.
• Support design control activities, including product performance, assembly integrity, safety, labeling, packaging, as well as verification and validation tasks.
• Collaborate with stakeholders to establish project scope, validation strategies, and requirements in dynamic development environments.
• Ensure compliance of all projects with FDA, ISO 13485, GMP, and MDR standards.
• Deliver executive-level project status updates and communications.

Skills

Medical Device NPD

Design Controls

Regulatory Submissions

Cross-functional leadership

Project management

FDA 510(k) knowledge

Education

Bachelor's degree

Tools

MS Project

Excel

PowerPoint

SharePoint

Job description

Weekday is seeking a Senior Project Manager – R&D with deep expertise in Medical Device New Product Development (NPD) to lead enterprise-level, FDA-regulated R&D initiatives. Based in San Clemente, CA, the role is hybrid, overseeing design controls, regulatory submissions, and product launches.

You will drive cross-functional collaboration across R&D, Regulatory, Quality, Operations, and Supply Chain to ensure timely, compliant project delivery from concept to launch.