Manufacturing EngineerCynet Systems • Draper, UT
Manufacturing Engineer
Cynet Systems • Draper, UT
29 days ago
Job type
- Full-time
Job description
Job Description:
Pay Range: $37.59hr - $42.59hr
Job Description:
Pay Range: $37.59hr - $42.59hr
- The Manufacturing Engineer is responsible for optimizing and supporting manufacturing processes through continuous improvement initiatives, process validation, documentation, and cross-functional collaboration.
- This role focuses on improving manufacturing efficiency, ensuring compliance, and supporting production through engineering expertise in a regulated environment.
- Optimize manufacturing processes using engineering methods such as Lean and Six Sigma to improve efficiency and quality.
- Design, redesign, or improve equipment, tools, fixtures, and manufacturing processes.
- Develop and execute moderately complex experiments and validation tests, including writing protocols and analyzing results.
- Analyze and resolve manufacturing and compliance issues including CAPA, non-conformances, and audit observations.
- Develop training materials and work instructions to support production and knowledge transfer.
- Establish and manage project plans, including risk analysis and timelines, to meet customer expectations.
- Oversee manufacturing support activities and provide guidance, training, and feedback to technicians.
- Coordinate technician activities and manufacturing support tasks.
- Collaborate with cross-functional teams, including R&D and commercial teams, across multiple sites.
- Coordinate manufacturing builds and raw material allocation.
- Lead process validations including IQ, OQ, and PQ.
- Support documentation activities for the manufacturing team.
- Bachelor’s degree in Engineering or a scientific field with a minimum of two years of related industry experience, or a Master’s degree in Engineering or a scientific field.
- Basic understanding of statistical techniques.
- Knowledge of Environmental Health and Safety and Quality guidelines in a cleanroom or regulated manufacturing environment.
- Knowledge of applicable FDA regulations for the medical device industry.
- Strong attention to detail.
- Ability to work effectively in a team environment and collaborate with multiple stakeholders.
- Ability to manage competing priorities in a fast-paced environment.
- Experience working in medical device or other regulated industries.
- Experience with process validation activities including IQ, OQ, and PQ.
- Experience supporting manufacturing line design, process creation, and process improvement.
- Experience with design transfer and Design for Manufacturing principles.
- Experience working in cleanroom environments preferred.
- Strong documentation, communication, and interpersonal skills.
- Proficiency with Microsoft Office applications including MS Project.
- Strong organizational, analytical, and problem-solving skills.
- Ability to manage complex projects with minimal supervision.
- Ability to adapt to changing priorities and project requirements.
- Strong time management skills to ensure timely task completion.
- Ability to interact professionally with all organizational levels.
- Ability to manage vendors and project stakeholders.
- Bachelor’s degree in Engineering or a related scientific discipline required.
- Master’s degree preferred.
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Manufacturing Engineer • Draper, UT
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