Engineer - Degreed IV

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We are seeking an Engineer - Degreed IV for a very important client.

Responsibilities:
? Focus of the role is on NPI and production capacity expansion through the introduction of high volume, fully automated production lines into a TPM facility
? Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs, and to meet strategic goals and objectives of the company.
? Prepares reports, publishes, and makes presentations to communicate findings to Management
? Partner with TPM engineering and operations partners to seamlessly deliver added production capacity to an existing operation
? Works with a global team to align and implement best practices across existing and new product lines
? Communicate effectively and engage cross functional team on all aspects and responsibilities required of equipment installation and qualifications.
? Ensure the project meets the requirements of all key internal stakeholders including but not limited to internal (ADC) R&D, Regulatory, and Quality groups
? Ensure project adherence to the required ADC policies and procedures.
? Manages changes on new and existing production lines
? Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advance problems which require novel and new innovative approaches or a major breakthrough in technology.
? Understands engineering principles theories, concepts, practices and techniques.
? Understands the business needs of the company and has knowledge of the customer needs of our business.
Requirement:
The ideal candidate will possess the following qualifications:

Required:
? Bachelor?s degree plus 6 years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.
? Medical device experience
? Strong understanding of business unit function and cross group dependencies/relationships.
? Demonstrated ability to directly use data to analyze and solve problems
? Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
? Has sound knowledge of various technical alternatives and their impact.
? Candidate must be a self-starter who can drive efficient and effective results/improvements with little to no direct supervision.
? Demonstrated ability to lead highly complex NPI projects in federally regulated environments
? Candidate must possess excellent communication (both written and oral) and team building skills to be successful in the position
? Highly organized with the ability to prioritize tasks to accomplish assigned goals
? Familiarity?with?qualification?and?regulatory?requirements?in?the?medical?device?industry, including?Design Review, User Requirement Specifications (URS), FAT, SAT, IQ/OQ/PQ,?ISO 8,?etc.

Preferred:
? Advance degree preferred.
? Demonstrated experience in validating new production lines and sustaining their validate states
? Experience in mid to high-volume complex automation equipment preferred
? May either come from machine building background or in manufacturing sector with experience of bringing automation lines from start to full efficiency.
? Experience with CAD programs such as AutoCAD, SolidWorks, etc.
? Experience with MS Project and SAP. PMP certification beneficial but not required.
? Strong mechanical and electrical aptitude.
How to Apply:
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