Design Control Engineer
Location: Ogden Utah
Description: Fresenius Medical Care is currently interviewing Design Control Engineer right now, this occupation will be placed in Utah. Detailed specification about this occupation opportunity please read the description below. PURPOSE AND SCOPE :
Supports FMCNA’s mission, vision, core values and customer service philosophy. Adheres to the FMCNA Compliance Program, including following all regulatory ! and division/company policy requirements.
Provides design control expertise and technical support to FMCNA’s Design and Development Quality Assurance process. The individual filling this role will contribute to new product development and design changes, not just from a compliance standpoint, but also from a technical oversight standpoint.
DUTIES / ACTIVITIES :
CUSTOMER SERVICE :
Responsible for driving the FMCNA culture through values and customer service standards.
Accountable for outstanding customer service to all external and internal customers.
Develops and maintains effective relationships through effective and timely communication.
Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.
PRINCIPAL RESPONSIBILITIES AND DUTIES :
Guide new product development and design changes ensuring product quality, reliab! ility, speed to market, reduction of risk to users and patient! s, and regulatory compliance.
Reviews and approves Verification and Validation methods for sterile medical devices, including performance, biocompatibility, sterilization, and manufacturing processes to ensure Design Input is met.
Assists in the determination of sample size, confidence levels, and associated statistics pertaining to Verification and Validation activities.
Responsible for Risk Management, documentation, and assurance that Design and Manufacturing process changes are assessed for potential risks to patients or regulatory compliance.
Assist the Quality Assurance function to build a comprehensive Design Assurance system compliant to FDA requirements, by reviewing Design Control procedures and policies, and assisting in document writing.
Provides assistance and mentorship to FMCNA manufacturing locations to implement an improved and robust Design Control system.
Reviews product change notices and change docum! entation to ensure thorough review of quality documents submitted for technical changes, design changes or manufacturing changes in order to ensure all regulatory requirements related to these changes are completely followed and conform to the Design Control regulations.
Application of Reliability requirements, Design Control and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO13485, ICH Q9, IEC 60601 and ISO 14971 Risk Management.
Other duties as assigned.
EDUCATION: Bachelor’s Degree in Engineering or a similar technical field required.
EXPERIENCE AND REQUIRED SKILLS :
A Minimum of 5 years of Medical Device or Pharmaceutical industry experience in a Mechanical, or Chemical Engineering role or equivalent required.
Experience preferably includes product or process design and development or quality engineering of sterile disposables utilizing various plastic processes such as ! injection molding and extruding.
The individual in this positi! on possesses an intimate understanding of Design Controls and solid engineering expertise enabling them to guide the development of new products and design changes.
Excellent computer and writing skills.
Must have knowledge and understating of Medical Device Regulation and Quality Assurance (e.g.) ISO9001, ISO 13485, ISO14971, IEC 60601; FDA 21 CRF820.30.
Experience with development of Design Input and traceability through V&V activities.
Experience with identification of relevant compliance standards and associate testing
Demonstrated presentation and communication skills
Ability to communicate technical information to non technical audiences.
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If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Fresenius Medical Care.
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This occupation starts available on: Tue, 04 Jun 2013 13:43:50 GMT