Research And Development Engineer
1 day ago
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
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