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Engineering Project Manager - Medical Devices

Engineering Project Manager - Medical Devices

Intellectt IncSkaneateles, NY, US
1 day ago
Job type
  • Full-time
Job description

Job Summary :

Lead cross-functional teams in complex engineering assignments, ensuring compliance with medical device regulations and effective project execution. This role requires a strong focus on project management, collaboration, and problem-solving across traditional product lines.

Primary Responsibilities

  • Independently plan, execute, and direct cross-functional engineering projects, adapting standard engineering principles to develop innovative solutions.
  • Manage projects consisting of cross-functional teams (including but not limited to regulatory, risk management, quality, technical communications, and supplier quality)
  • Oversee all financial aspects of product development, including capital expenditures and cross-functional expenses.
  • Identify and resolve complex problems, developing new solutions as needed for project roadblocks

Knowledge

  • Medical Device Regulations : In-depth understanding of FDA regulations, ISO standards, and other relevant guidelines governing medical device labeling and compliance.
  • Project Management Methodologies : Familiarity with project management frameworks (e.g., Agile, Waterfall) and tools (e.g., Gantt charts, project management software).
  • Engineering Principles : Strong foundation in engineering principles relevant to medical device design and development.
  • Quality Management Systems (QMS) : Knowledge of QMS practices and documentation requirements.
  • Cross-Functional Team Dynamics : Understanding of the roles and responsibilities of various departments involved in medical device development.
  • Skills

  • Project Management Skills : Proven ability to manage multiple projects simultaneously, ensuring timely delivery within budget.
  • Analytical Skills : Strong analytical and problem-solving skills to identify issues and develop effective solutions.
  • Communication Skills : Excellent verbal and written communication skills for diverse audiences.
  • Leadership Skills : Ability to lead and motivate cross-functional teams.
  • Attention to Detail : Meticulous attention to detail in reviewing labeling documentation.
  • Abilities

  • Independent Judgment : Ability to make informed decisions in evaluating engineering techniques.
  • Adaptability : Flexibility to adapt to changing project requirements and industry trends.
  • Time Management : Strong organizational skills with effective prioritization.
  • Interpersonal Skills : Ability to build and maintain positive working relationships.
  • Continuous Learning : Commitment to staying current with industry developments.
  • Qualifications

  • Bachelor's degree in Engineering or a related field.
  • 8-10 years of relevant experience in project management, with a focus on medical devices.
  • 2-5 years of experience in matrix management.
  • Thorough, up-to-date knowledge of multiple engineering disciplines.
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    Project Manager • Skaneateles, NY, US

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