Senior Electro Mechanical Engineer - Medical Products ONSITE / USC/GC/H4EAD/ L2EAD Job at Raag Solutions, Minnesota

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  • Raag Solutions
  • Minnesota

Job Description

SHOULD WORK IN W2
ONSITE - USC/GC/H4EAD/ L2EAD

Key Responsibilities:

  • Mechanical and Electrical Expertise: Design, develop, and sustain mechanical and electrical systems for medical products, including sterilization and temperature monitoring equipment and biological indicator incubators.
  • Change Control Process: Manage and execute change control processes to ensure compliance with regulatory standards and maintain product quality.
  • Cross-Functional Team Collaboration: Work closely with quality, regulatory, manufacturing, and supply chain teams (both internal and external) to execute and implement tasks and drive projects to completion.
  • Alternate Part Identification: Identify and qualify alternate parts to ensure product continuity and cost efficiency.
  • Global Team Coordination: Coordinate with global teams, including onsite and offshore resources, to ensure seamless project execution and communication.
  • Project Management: Lead and manage projects, ensuring timely delivery and adherence to quality standards.
  • Documentation and Compliance: Maintain detailed documentation to support compliance with regulatory requirements and internal standards.

Qualifications:

  • Education: Bachelor’s degree in Engineering is required; a Master’s degree in Engineering is preferred.
  • Experience:  Minimum of 10 years of experience working with medical device manufacturers .

Skills:

  • Strong mechanical and electrical engineering skills.
  • In-depth knowledge of sterilization and temperature monitoring systems.
  • Proven experience with change control processes.
  • Ability to work effectively with cross-functional teams.
  • Experience in identifying and qualifying alternate parts.
  • Strong project management and leadership skills.
  • Excellent communication and coordination skills for global team management.
  • Regulatory Knowledge: Familiarity with regulatory requirements and standards for medical devices (e.g., ISO 13485, EU-MDR).

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