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
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
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.
