Staff Technologist, Maintenance/Manufacturing Support Engineer

About the role

Edwards is looking for a Staff Technologist to provide technical manufacturing support to Operations and Engineering. The role acts as a key Subject Matter Expert in asset management, equipment maintenance and manufacturing support, and covers project management, equipment validation and process improvement.

Key responsibilities

• Design, set up and run complex feasibility studies, experiments and tests, following established protocols, and report findings to Engineering for validation and process improvement
• Manage projects end to end using tools such as Microsoft Project and Gantt charts, coordinating resources, priorities and issues
• Collaborate with Engineering on root cause investigations for CAPA
• Review documentation so that equipment information is properly catalogued and transferred to ECRs, SOPs, drawings and tooling for Engineering approval
• Lead projects to develop new complex tools and equipment, and design, develop and sustain processes and training methods
• Use manufacturing software (JDE, QMS, PLM) to update documentation in systems such as ECRs and Blue Mountain
• Coach and guide technicians, and work independently on complex projects and work instructions

Required profile

• H.S. Diploma or equivalent with 15 years of related experience, or Associate's degree or equivalent with 13 years
• 15 years of manufacturing and/or medical device experience preferred
• Full-time attendance, punctual, with a full 8-hour or longer work day
• Knowledge of Edwards environmental health, safety and quality guidelines for clean room medical device manufacturing, and adherence to Good Manufacturing and Good Documentation Practices

Required skills

• Root cause analysis, problem solving and presentation skills
• Extensive knowledge of validation and preventive maintenance of production equipment
• Electrical, mechanical, electronic, pneumatic and controls knowledge
• Material compatibility and troubleshooting of manufacturing equipment
• Project management fundamentals
• Strong computer skills, including MS Office; CAD if applicable