Position Title: Manufacturing Engineer II
Assignment Duration: 12 Months
Work Location: Draper, Utah 84020
 
How you will make an impact:

• Optimizing manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills.
• Developing moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.
• Analyzing and resolving moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
• Establishing project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work
• Collaborating across sites and cross functional teams (R&D and commercial).
• Coordinating manufacturing builds and raw material allocations.
• Leading process validations (IQ, OQ, PQ).
• Supporting documentation for the team.

 
What you’ll need (Required):

• A Bachelor's degree in Engineering or Scientific field with 2 years of previously related industry experience OR Master’s degree in Engineering or Scientific field Required.  

 
What else we look for (Preferred):

• Good computer skills in usage of MS Office Suite including MS Project.
• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Strong Organizations skills with the ability to manage complex projects/tasks
• Good adaptability in changing projects, directions, and priorities
• Good time management skills to ensure timely completion of tasks
• Ability to drive tasks with minimal supervision; self-starter
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment preferred
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to client’s Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• Understanding of Phase-gate product development
• Medical device or regulated industry experience
• Understanding of design requirements documentation, risk management plans, inspection criteria, test method development and validation activities
• Cleanroom environment experience
• Knowledge of manufacturing line design
• Knowledge of process creation and process improvement
• Knowledge of process and design transfer activities
• Understanding/knowledge of Design for Manufacturing (DFM) principles

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 38.00/hr.