Responsibilities:

• Lead and manage multidisciplinary teams throughout the product development lifecycle.
• Develop and execute project plans, ensuring milestones and deadlines are met.
• Monitor project progress and address any deviations or delays promptly.
• Establish and implement design control procedures and processes throughout the product development lifecycle.
• Support design reviews, risk assessments, and verification/validation activities to ensure product quality and safety.
• Identify potential risks and challenges associated with projects throughout the design and development process.
• Conduct user needs assessments and usability studies to gather feedback and refine the device's design.
• Generate and maintain accurate and comprehensive project documentation.
• Provide project reports and updates to management and stakeholders on project progress, risks, and mitigation strategies.

Qualifications:

• Bachelor’s or higher degree in engineering, biomedical sciences, or related fields.
• Familiarity with medical device regulations, including FDA regulations and ISO standards.
• Proven experience in project management within the medical device industry or other regulated industries.
• Understanding of quality management systems (e.g., ISO 13485) and design control processes.
• Excellent communication and leadership skills to facilitate cross-functional collaboration.
• Strong analytical and problem-solving abilities to support product development teams.
• Certification in project management (e.g., PMP) is preferred, as well as knowledge of Six Sigma or Lean principles.
• Skilled at conflict management and resolution, and must have excellent interpersonal skills
• High proficiency with project management tools, including Gantt charts, spreadsheets, presentations, and collaboration software. Working experience with monday.com project management software is a plus.
• Exhibits enthusiasm, upbeat, professional attitude, integrity, reliability, and leadership
• Ability to work in a dynamic environment that requires critical thinking and strong analytical skills