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11 days ago
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Principal Manufacturing Engineer


Salary band: $10k - $15k
Location: North America, United States, Minnesota, Minneapolis
Job type: Permanent
Contact: Entegee Engineering Technical Group
Category: Engineer
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Develops/implements production/processing methods and controls to meet quality standards in most cost efficient manner. Investigates and resolves work-in-process problems. Recommends and implements improvements and/or modifications in sequence of operations, equipment utilization and related matters. Monitors assigned operations to assure compliance with approved methods and standards.
The Manufacturing Engineer will perform industrial and manufacturing engineering duties necessary to support new product development and the deployment of a custom manufacturing process for a chemical based cartridge used within a new kidney dialysis platform. This position will work in collaboration with a global team on the design for manufacturability and the establishment of manufacturing within China and other geographies as required. This will include the support of a prototype manufacturing line to develop the manufacturing process and to support the design of the product. Initial responsibility will be focused on the transfer of manufacturing processes required to produce the sorbent cartridge in high volume applications. The identification of processes, manufacturing techniques and the selection of high volume manufacturing equipment with supporting automation will be critical. The qualified candidate will work with a cross-functional global team to fully leverage internal/external resources to provide manufacturing and chemical engineering expertise to support the needs for China and additional markets as necessary.
?
Key activities will be to 1) support design activity to promote manufacturability in a high volume manufacturing environment 2) develop proto and production manufacturing strategies in support of the products 3) identify and help procure manufacturing equipment that meets market needs 4) support the manufacturing needs of the business through full scale manufacturing, and 5) provide design for reliability and manufacturability input to the design organization and component manufacturers.
?


The Manufacturing Engineering must be an expert in the design and manufacture of medical devices. A candidate with experience in the manufacture of chemical filtration is desired. They must have an entrepreneurial spirit, a can do attitude, be comfortable dealing with ambiguity, and to be confident about being able to apply business acumen to help make pragmatic trade-off decisions between time-to-market, product costs, product reliability, product features, manufacturing requirements and budget. An engineering degree or applicable technical field and past experience in the manufacture of chemical based subsystems or materials for medical products is required for this position.

Additional Qualifications:
?Solid in fundamentals of manufacturing engineering with experience in automation
?Experience with physical processes involving granular solids or powders including: blending, sizing/classification, drying, mixing, conveying and dispensing. Experience with the design and scale-up of such systems.
?Vendor selection and management experience
?Fundamental understanding of packed-bed purification systems (also known as packed-columns or sorbent columns) used for liquid purification (based on adsorption or ion-exchange) and reactions. Understanding should include theory of operation, testing procedures, column design and optimization, and regeneration methodology.
?Experience with synthesis/manufacturing process and scale-up of chemicals such as zeolites, zirconium compounds, activated carbon, alumina, ion-exchange resins, etc.
?Project management experience
?Full product life-cycle experience (definition-development-released)
?Strong working knowledge of the latest manufacturing engineering and related product design practices with a familiarity in Lean and Kaizen activities preferred.
?Exceptional math and analytical skills to adequately analyze manufacturing needs from equipment selection to the detailed lean process flows required for high volume manufacturing
?Ability to perform Make vs. Buy analysis
?Full product life-cycle experience
?A BS or MS in Chemical or Industrial Engineering or Chemistry with 10 years industrial experience in medical applications
?Excellent interpersonal, written and verbal communication skills; Individual must communicate well with all levels of management and employees as well as customers and external collaborators
?Execution oriented, driven, and self-motivated. Ability to work autonomously and within a team setting.
?Strong negotiation skills and ability to influence others.
?Able to work effectively in heavily matrixed environment.
?Able to work in direct, cross-functional and cross-cultural teams.
?Able to develop objectives, work plans and measurements that are aligned with program strategies.
?Demonstrated experience in meeting time to market needs with a high quality product.
?Strong organization and time management skills; ability to manage multiple priorities.
?Self-starter, strong work ethic and initiative in accomplishing objectives.
?Experience and ability to resolve complex manufacturing issues
?Experience working in a regulated industry such as Medical, Food, or Aerospace.
?Speak and write English fluently. Mandarin is a plus.
?Able to travel domestically and internationally
Required: Degree in Manufacturing Engineering. More than 10 years of experience.
Develops/implements production/processing methods and controls to meet quality standards in most cost efficient manner. Investigates and resolves work-in-process problems. Recommends and implements improvements and/or modifications in sequence of operations, equipment utilization and related matters. Monitors assigned operations to assure compliance with approved methods and standards.
The Manufacturing Engineer will perform industrial and manufacturing engineering duties necessary to support new product development and the deployment of a custom manufacturing process for a chemical based cartridge used within a new kidney dialysis platform. This position will work in collaboration with a global team on the design for manufacturability and the establishment of manufacturing within China and other geographies as required. This will include the support of a prototype manufacturing line to develop the manufacturing process and to support the design of the product. Initial responsibility will be focused on the transfer of manufacturing processes required to produce the sorbent cartridge in high volume applications. The identification of processes, manufacturing techniques and the selection of high volume manufacturing equipment with supporting automation will be critical. The qualified candidate will work with a cross-functional global team to fully leverage internal/external resources to provide manufacturing and chemical engineering expertise to support the needs for China and additional markets as necessary.
?
Key activities will be to 1) support design activity to promote manufacturability in a high volume manufacturing environment 2) develop proto and production manufacturing strategies in support of the products 3) identify and help procure manufacturing equipment that meets market needs 4) support the manufacturing needs of the business through full scale manufacturing, and 5) provide design for reliability and manufacturability input to the design organization and component manufacturers.
?


The Manufacturing Engineering must be an expert in the design and manufacture of medical devices. A candidate with experience in the manufacture of chemical filtration is desired. They must have an entrepreneurial spirit, a can do attitude, be comfortable dealing with ambiguity, and to be confident about being able to apply business acumen to help make pragmatic trade-off decisions between time-to-market, product costs, product reliability, product features, manufacturing requirements and budget. An engineering degree or applicable technical field and past experience in the manufacture of chemical based subsystems or materials for medical products is required for this position.

Additional Qualifications:
?Solid in fundamentals of manufacturing engineering with experience in automation
?Experience with physical processes involving granular solids or powders including: blending, sizing/classification, drying, mixing, conveying and dispensing. Experience with the design and scale-up of such systems.
?Vendor selection and management experience
?Fundamental understanding of packed-bed purification systems (also known as packed-columns or sorbent columns) used for liquid purification (based on adsorption or ion-exchange) and reactions. Understanding should include theory of operation, testing procedures, column design and optimization, and regeneration methodology.
?Experience with synthesis/manufacturing process and scale-up of chemicals such as zeolites, zirconium compounds, activated carbon, alumina, ion-exchange resins, etc.
?Project management experience
?Full product life-cycle experience (definition-development-released)
?Strong working knowledge of the latest manufacturing engineering and related product design practices with a familiarity in Lean and Kaizen activities preferred.
?Exceptional math and analytical skills to adequately analyze manufacturing needs from equipment selection to the detailed lean process flows required for high volume manufacturing
?Ability to perform Make vs. Buy analysis
?Full product life-cycle experience
?A BS or MS in Chemical or Industrial Engineering or Chemistry with 10 years industrial experience in medical applications
?Excellent interpersonal, written and verbal communication skills; Individual must communicate well with all levels of management and employees as well as customers and external collaborators
?Execution oriented, driven, and self-motivated. Ability to work autonomously and within a team setting.
?Strong negotiation skills and ability to influence others.
?Able to work effectively in heavily matrixed environment.
?Able to work in direct, cross-functional and cross-cultural teams.
?Able to develop objectives, work plans and measurements that are aligned with program strategies.
?Demonstrated experience in meeting time to market needs with a high quality product.
?Strong organization and time management skills; ability to manage multiple priorities.
?Self-starter, strong work ethic and initiative in accomplishing objectives.
?Experience and ability to resolve complex manufacturing issues
?Experience working in a regulated industry such as Medical, Food, or Aerospace.
?Speak and write English fluently. Mandarin is a plus.
?Able to travel domestically and internationally
Required: Degree in Manufacturing Engineering. More than 10 years of experience.

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