The Process Engineer will be responsible for engineering support and direction for current manufacturing activities and the support of development and commercialization of new products and line extensions.
Summary of Position with General Responsibilities: Support production team activities including:
Work Instruction changes relating to process changes
Concept development and design input, project plans/schedules, and design reviews and design for manufacturability
Assist in ensuring the QSR compliance of design control process in product development.
Knowledge or ability to learn DOE’s, process validations, and other QSR requirements.
Plan, coordinate and manage current manufacturing activities and assist in the launch and commercialize new products including:
Concept and development of methods and processes
Coordination and support of new vendors, tooling, equipment and molds
Development and release of product and process documentation
Qualification and validation of new operations and processes
Support new product cost estimates
Support the preparation of the AFE (Authorization for Expenditure)
Evaluation, test and recommendation of new materials
Support through planning, coordination and management of activities to transfer new products from design to manufacturing including:
Support the development and management of a transition plan and team
Support documentation, methods and labor standards review
Assist in the development of component inventory transition plans
Support facility selection, coordination and preparation activities
Manage equipment moves and installation
Provide validation and training support
Basic Qualifications:
Must be a self-starter.
Be able to work without the need for supervision.
Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
Plans effectively and team oriented.
Familiar with project management and critical path planning.
Have effective oral and written communication skills.
Requires working knowledge of average computer/PC skills with experience in Microsoft Word, Excel, Project and PowerPoint, network systems (electronic mail) and Internet applications. Statistical analysis program knowledge is a plus.
Proven track record demonstrating the manufacturing implementation of innovative, low cost disposables. Must possess Engineering knowledge at the level normally attained through a minimum of a bachelor degree program. Proven ability to interface with various levels of the organization.
Education and/or Experience:
A minimum of a BS degree in a technical field such as biomedical engineering, chemistry, chemical engineering, mechanical engineering or other engineering field is needed to perform this job. Knowledge and training of project management, QSR, process engineering and/or design control processes is a plus.
Minimum of 3-5 years experience in consumer/medical manufacturing or process engineering is needed to perform this job. Experience with OEE and process capability studies and Six Sigma certifications are a plus.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear. The employee will sometimes be required to move around in manufacturing facility. Specific vision abilities required by this job include close vision and color vision.
C. R. Bard - 9 months ago
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