Associate, Project Manager

JENAVALVE TECHNOLOGY INC•Irvine, CA

39d•$115,000 - $125,000

About The Position

Responsible for leading cross-functional teams through the development and launch of heart valves, delivery catheters, and related components, ensuring projects meet regulatory compliance, quality standards, and timelines while managing budgets, risks, and stakeholder expectations within the complex landscape of medical device development and commercialization. Projects may span globally across the organization to address the most critical business needs including Product Development, Operations, Quality and Regulatory.

Requirements

Bachelor's degree in Engineering, Biomedical Sciences, or a related field.
Minimum 3 years’ experience in project management/leading teams to implement product/manufacturing process improvements and/or develop complex line extensions or new products (within R&D, Manufacturing, Quality, Clinical or Regulatory).
Project Management Expertise: Proven experience in managing projects from concept to commercialization, ideally within the medical device industry.
Technical Knowledge: Understanding of medical device design principles, manufacturing processes, and regulatory requirements.
Must take initiative and have the ability to create/edit/review documentation and timelines using standard MS Office tools.
Leadership Skills: Ability to lead cross-functional teams, motivate individuals, and foster collaboration.
Communication Skills: Excellent written and verbal communication skills to effectively convey complex technical information to diverse stakeholders.
Regulatory Compliance: Familiarity with FDA regulations and other relevant international standards for medical devices.
Problem-solving and Critical Thinking Skills: Ability to analyze complex situations, identify root causes, and develop effective solutions.
Flexibility: Ability to manage multiple projects/tasks with high attention to detail.
Support global teams of varying size and focus across multiple time zones.

Nice To Haves

Experience in FDA environment for PMA or NDA product development is highly desirable.
Project Management Professional (PMP) or equivalent project management training certification desired.

Responsibilities

Project Planning & Execution: Develop comprehensive project plans, including scope definition, timelines, milestones, resource allocation, and budget management.
Lead cross-functional teams consisting of engineers, clinicians, regulatory specialists, quality assurance personnel, and marketing teams.
Manage project schedules, track progress against key performance indicators, and identify potential roadblocks to mitigate risks.
Ensure adherence to regulatory requirements (FDA, ISO, etc.) throughout the product development lifecycle.
Technical Expertise: Understand medical device design principles, functionality, and technical specifications relevant to the project.
Collaborate with engineering teams to translate product requirements into technical design documents.
Stay updated on emerging technologies and industry trends in medical device development.
Stakeholder Management: Facilitate communication and collaboration between different departments, including clinical research, manufacturing, sales, and marketing.
Present project updates and key decisions to senior management and stakeholders.
Manage stakeholder expectations and address concerns effectively.
Risk Management: Identify and proactively mitigate potential risks associated with the project, including technical, regulatory, and clinical risks.
Develop contingency plans to address unforeseen challenges and ensure project continuity.
Quality Assurance: Ensure compliance with quality management systems (QMS) and standard operating procedures (SOPs) throughout the project.
Monitor and address quality issues to maintain product safety and efficacy.