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Lead Electro-Mechanical Engineer

2 months ago

Minneapolis, Minnesota, United States Connvertex Technologies Inc. Full time
Position Overview

Senior Electro-Mechanical Engineer for Medical Technologies

Company: Connvertex Technologies Inc.

We are seeking a highly skilled Senior Electro-Mechanical Engineer with a robust background in both mechanical and electrical engineering, specifically tailored for medical technology applications. The successful candidate will possess significant experience in sterilization processes, temperature control systems, and incubators for biological indicators.

Key Responsibilities:

  • Engineering Expertise: Design, develop, and maintain mechanical and electrical systems for medical technologies, focusing on sterilization and temperature control systems, as well as biological indicator incubators.
  • Regulatory Compliance: Oversee and implement change control processes to ensure adherence to industry regulations and maintain high product quality standards.
  • Collaborative Engagement: Partner with cross-functional teams, including quality assurance, regulatory affairs, manufacturing, and supply chain, to execute tasks and drive projects to successful completion.
  • Parts Management: Identify and validate alternative components to ensure product reliability and cost-effectiveness.
  • Global Coordination: Facilitate collaboration with international teams, including both onsite and remote resources, to ensure effective project execution and communication.
  • Project Leadership: Lead project initiatives, ensuring timely delivery while adhering to quality benchmarks.
  • Documentation: Maintain comprehensive documentation to support compliance with regulatory standards and internal protocols.

Qualifications:

  • Education: A Bachelor's degree in Engineering is essential; a Master's degree is preferred.
  • Experience: A minimum of 10 years in the medical device manufacturing sector is required.

Essential Skills:

  • Mechanical and Electrical Proficiency: Strong skills in both mechanical and electrical engineering.
  • Knowledge of Sterilization: In-depth understanding of sterilization and temperature monitoring systems.
  • Change Control Expertise: Proven track record in managing change control processes.
  • Team Collaboration: Ability to work effectively within cross-functional teams.
  • Parts Qualification: Experience in identifying and qualifying alternative components.
  • Leadership and Management: Strong project management and leadership capabilities.
  • Communication Skills: Excellent coordination and communication skills for managing global teams.
  • Regulatory Acumen: Familiarity with medical device regulatory requirements and standards (e.g., ISO 13485, EU-MDR).