Global Medical Device Program Lead

Jenavalve Technology Inc; Irvine (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Jenavalve Technology Inc. is seeking an Associate, Project Manager to lead cross-functional teams through development and launch of heart valves, delivery catheters, and related components.

You will ensure regulatory compliance, quality, and timelines while managing budgets and risks across a global organization. The role requires 3+ years in project management within medical devices, familiarity with FDA processes (PMA/NDA) is desirable, and PMP or equivalent training is preferred.

Qualifications

• Bachelor's degree required.
• Minimum 3 years’ project management experience leading teams to develop/manufacture complex products.
• PM in FDA PMA/NDA environments is highly desirable.
• PMP or equivalent certification desired.

Responsibilities

• Develop comprehensive project plans with scope, timelines, milestones, resources and budget.
• Lead cross-functional teams of engineers, clinicians, regulatory, QA and marketing.
• Manage schedules, monitor KPIs, and mitigate roadblocks to meet timelines.
• Ensure compliance with regulatory requirements (FDA, ISO) throughout product development.
• Present updates to senior management and stakeholders and manage expectations.

Skills

Project management

Technical knowledge

Leadership

Communication

Regulatory compliance

Problem solving

Flexibility

Education

Bachelor's degree in Engineering, Biomedical Sciences, or related field

Tools

MS Office

Job description

Jenavalve Technology Inc. is seeking an Associate, Project Manager to lead cross-functional teams through development and launch of heart valves, delivery catheters, and related components.

You will ensure regulatory compliance, quality, and timelines while managing budgets and risks across a global organization. The role requires 3+ years in project management within medical devices, familiarity with FDA processes (PMA/NDA) is desirable, and PMP or equivalent training is preferred.