Job Summary:

The R&D Project Manager is responsible for leading and managing the design and development of medical devices from conception through to commercialization, ensuring compliance with regulatory standards, quality guidelines, and company objectives. This role involves coordinating cross-functional teams, overseeing project timelines, mitigating risks, and ensuring that the final product meets safety, efficacy, and usability requirements.

Responsibilities:

• Lead and manage multidisciplinary teams throughout the product development lifecycle.
• Develop and execute project plans, ensuring that 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:

• Bachelors 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 industry.
• 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) preferred and knowledge of Six Sigma or Lean principles.
• Skilled at conflict management and resolution, and must have excellent interpersonal skills
• High level of proficiency with project management tools including Gantt charts, spreadsheets, presentations, and collaboration software. Working experience with monday.com project management software is a plus.
• Ability to work in a dynamic environment that requires critical thinking and strong analytical skills
• Exhibits enthusiasm, positive professional attitude, integrity, reliability, and leadership