Manufacturing EngineerCynet Systems • Draper, UT

Manufacturing Engineer

Cynet Systems • Draper, UT

26 days ago

Job type

Full-time

Job description

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.

Responsibilities:

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.

Requirement/Must Have:

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:

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.

Skills:

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.

Qualification And Education:

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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