Program Manager

As a Program Manager, you will lead cross-functional teams to deliver innovative and compliant medical device solutions from concept through commercialization. You will be responsible for managing complex programs, ensuring alignment with strategic objectives, and driving execution across engineering, regulatory, quality, manufacturing, and marketing functions.

Key Responsibilities:

• Program Leadership: Drive the planning, execution, and delivery of medical device programs, ensuring scope, schedule, budget, and quality targets are met.
• Cross-Functional Collaboration: Facilitate communication and coordination among engineering, clinical, regulatory, and operations teams.
• Risk Management: Identify program risks and develop mitigation strategies to ensure successful outcomes.
• Stakeholder Engagement: Communicate program status, milestones, and risks to senior leadership and key stakeholders.
• Regulatory Compliance: Ensure programs adhere to FDA, ISO 13485, and other applicable regulatory standards.
• Resource Management: Allocate resources effectively and manage external vendors or partners as needed.
• Continuous Improvement: Champion process improvements and best practices in program management and product development.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field (Master's or PMP certification preferred).
• 8+ years of experience in program or project management within the medical device industry.
• Strong understanding of design controls, product lifecycle management, and regulatory requirements.
• Proven ability to lead cross-functional teams and manage multiple complex projects.
• Excellent communication, organizational, and problem-solving skills.

Preferred Skills:

• Experience with Class II or Class III medical devices.
• Familiarity with Agile and Waterfall project methodologies.
• Proficiency in project management tools (e.g., MS Project, Smartsheet, Jira).