Manufacturing Engineer -Plainfield, IN

Company Name:
## Description
This position provides engineering support for manufacturing, service and repair of portable medical devices. This position may take daily direction from manufacturing or senior manufacturing engineer. It will require a variety of technological skills which may include; mechanical, electrical, electronics, software, instrumentation, and project management.
Ensure that the production and/or service of products are maintained at the rate and quality levels assigned as required by applicable quality system and regulatory requirements.
Review and approve changes made to products that may impact production or service lines.
Continually look for ways to reduce the cost of the manufacturing and/or service by implementing innovative solutions and streamlining processes.
Generate manufacturing and/or process instructions.
Analyze process metrics and institute changes to maintain quality levels.
Provide project management direction and/or project support as a member of a project team.
May develop, implement and maintain validation process plans.
May provide mechanical, pneumatic and electrical support for test fixtures and automated/semi-automated test systems.
Translate strategic goals into operating plans.
Understand FDA, ISO and GMP requirements.
Be able to respond to changing priorities quickly and efficiently.
Handle various projects and responsibilities simultaneously and successfully meet deadlines.
Coordinate group efforts and provide leadership for project work.
Use computer skills in Microsoft Excel/Access/Word.
Work with other groups or individuals to resolve issues.
Other duties as assigned with or without accommodation.
## Qualifications
Education required/ preferred:
B.S. in a Technical field from an accredited four-year college or university or an equivalent combination of education and experience.
4-6 years of related experience with increased responsibility in Manufacturing and or service of electronic /electromechanical medical devices.
Preferred Skills/Qualifications:
Knowledge of medical device regulatory requirements. Experience with mechanical, electrical, electronics, software, and/or instrumentation technologies. Must have good troubleshooting and time management skills.
Excellent oral and written communication skills. MSWord, MS Project, Excel, and statistical software. Knowledge of product structures and manufacturing processes.
Other Skills:
Lean Manufacturing, Six Sigma, validation/qualification (IQ, OQ, PQ) experience, CAD skills, able to read technical drawing; ability to travel occasionally.
Reports to the Engineering Supervisor.
Must communicate effectively with various departments including purchasing and sustaining engineering.
Oversee certain tasks performed by engineering technicians.
Lead multi functional teams to drive cost reductions and maximize engineering synergies.
Active team member within the department.
Normal office conditions with routine visits throughout the warehouse, receiving and shipping areas. These areas include hazards for temperature fluctuation and light machinery such as forklift traffic. While performing the duties of this job, the employee is regularly required to sit, talk, hear and use hands and arms to reach. The employee is occasionally required to stand, walk, lift and use hands or fingers to handle office equipment, controls or to feel objects. Specific vision abilities required by this job include close vision and ability to adjust focus. The noise level in the office environment is low to moderate; in the warehouse areas, noise level may be moderate to high for short periods.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Primary Location: North America-United States-Indiana-Plainfield
Job: Manufacturing
Organization: United States
Job Posting: Jun 24, 2014, 2:56:30 PM
Req ID: 140001WO

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