Manufacturing & Service Engineer

6 days ago

Mississauga, Ontario, Canada Traferox Technologies Inc. Full time

Position Overview:

We are seeking a motivated and detail-oriented Manufacturing & Service Engineer to join our dynamic team at Traferox Technologies, a leading medical device company.

Your contributions will directly impact the quality, efficiency, and reliability of our medical devices, ensuring they meet the highest standards and provide exceptional patient care.

Duties & Responsibilities:

  • Analyze manufacturing processes to identify areas for improvement in efficiency, quality, and cost-effectiveness.
  • Develop and implement strategies to optimize production workflows, minimize downtime, and enhance overall manufacturing performance.
  • Developing new and improving existing manufacturing processes maps (PMAPs) and (PFMEAs) and Production qualification plans.
  • Utilize SolidWorks CAD software and engineering principles to design and develop mechanical components and assemblies for manufacturing and test jigs and fixtures.
  • Conduct feasibility studies and performance analyses to ensure design integrity, functionality, and manufacturability.
  • Collaborate with R&D and production teams to optimize designs for manufacturing efficiency, cost-effectiveness, and reliability.
  • Establish and maintain quality standards and procedures in accordance with regulatory requirements and industry best practices.
  • Verification and Validation of new equipment and of new processes.
  • Conduct IQ/OQ/PQ to qualify new JIGs/equipment.
  • Provide technical assistance to internal teams and external partners regarding product specifications, assembly procedures, and troubleshooting.
  • Respond to customer inquiries and service requests in a timely and professional manner, addressing technical issues and providing solutions to ensure customer satisfaction.
  • Travel to customer site to perform preventative maintenance work, training, troubleshooting repairs, upgrades and investigations.
  • Create and maintain technical documentation, including assembly instructions, troubleshooting guides, and service manuals.
  • Conduct training sessions for production staff and service technicians to ensure proper understanding and implementation of manufacturing processes and procedures.

Qualifications

Education:

  • Bachelor's degree in engineering, manufacturing, or related field; advanced degree preferred.

Experience:

  • 2+ years of experience in medical device manufacturing, with a strong background in production management, quality assurance, and regulatory compliance.

Skills and Knowledge:

  • Demonstrated leadership experience, with the ability to effectively lead and motivate teams in a fast-paced manufacturing environment.
  • In-depth knowledge of manufacturing processes, quality management systems, and regulatory requirements for medical devices, including FDA regulations and ISO standards.
  • Strong analytical skills and problem-solving abilities, with the ability to analyze complex issues, develop practical solutions, and drive results.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams, customers, and external partners.
  • Proven track record of driving process improvements, cost reductions, and operational efficiencies while maintaining high standards of product quality and customer satisfaction.
  • Experience with lean manufacturing principles, Six Sigma, or other continuous improvement methodologies is a plus.
  • Familiarity with ERP systems, manufacturing software, and data analysis tools is preferred.
  • Ability to travel occasionally to customer sites, suppliers, and other company locations as needed.

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