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Equipment Specialist Engineer

Orange County Metro Area, CA

Post Date: 05/03/2017 Job ID: JN -052017-18971
R&D Partners is hiring for a talented Equipment Specialist Engineer in the Medical Device industry.



-Experience with Software or PLC's
-Maintenance Equipment Mechanice
-Experience maintaining medical device equipment is required.

Must have utilized the tools of six sigma and have experience with software or PLCs (programmable logic controls). Also, must be very familiar and experienced with the operating systems of several pieces of equipment in a medical device company. Autocad experience and a Bachelor s degree in Engineering is required.

This position will start out as a contract position then convert to a regular position. This Engineer is going to be supporting equipment on the manufacturing floor and increasing uptime. Must be hands on with a high mechanical aptitude. Correct candidate will come from a medical device background. Will be responsible for support of all manufacturing equipment. Will be interfacing with Flo-Co and valve machines to test pressure and check for leaks. Will work with all sterilizers, autoclves and packaging equipment


-Optimize 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
-Develop moderately complex experiments and tests (including writing and executing protocols) to
qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
-Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, nonconformances, audit observations)
-Develop training and documentation materials (e.g., work instructions) for production to enable the
seamless knowledge transfer of project and manufacturing processes
-Establish project plans to ensure deliverables are completed to customer s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.) 10%
-Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train
technicians and provide feedback; and coordinate technician work

Education: BA in Engineering or Scientific Field
Experience: 2 year's of experience

Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including
consultative and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required (if applicable)
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 Edwards 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

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