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Fresenius Medical Care North America Design Assurance Engineer II in Ogden, Utah

Job ID 20000AVN

Available Openings 1

PURPOSE AND SCOPE:

Provides design control expertise and technical support to the Design and Development Quality Assurance process. Contributes to new product development and design changes, not just from a compliance standpoint, but also from a technical oversight standpoint.

PRINCIPAL DUTIES AND RESPONSIBILITIES :

  • Provides support for the launch and maintenance of Configuration Management processes from the Quality perspective, which supports transition from physical document based change control to an electronic configuration management capability

  • Assist with the upkeep and maintenance of Quality documentation from the global perspective for GPDM

  • Work with groups for implementing and maintaining the Configuration Management process within the Digital Engineering Strategy

  • Maintain and enforce configuration management policies and procedures

  • Develop best practices to improve integrity and quality of configuration processes

  • Provide support in system design, development, testing and implementation activities

  • Assist in preparation of system requirement, design documents and test strategies

  • Communicate system configuration status (accounting) to management and stakeholders on a routine basis

  • Assist in configuration verification and audits and communicate results to Managers

  • Assist with system configurations and migrations, as applicable

  • Work closely with development, quality and support teams to complete configuration tasks

  • With the use of configuration status accounting, develop process to be able to provide improvements

  • Application of Reliability requirements, Design Control, Configuration Management, and Risk Management and knowledge and familiarity with the concepts of FDA CFR 820, ISO13485, ICH Q9, ISO 10007, IEC 60601 and ISO 14971 Risk Management.

  • Guides new product development and design changes ensuring product quality, reliability, speed to market, reduction of risk to users and patients, 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.

  • Assists 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 company manufacturing locations to implement an improved and robust Design Control system.

  • Reviews product change notices and change documentation 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.

  • Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action.

  • Builds productive working relationships.

  • May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.

  • May refer to senior level staff for assistance with higher level problems that may arise.

  • Escalates issues to supervisor/manager for resolution, as deemed necessary.

  • Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

  • Assist with various projects as assigned by direct supervisor.

  • Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS :

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Occasional travel required.

EDUCATION :

Bachelor’s Degree in Engineering or a similar technical field required

EXPERIENCE AND REQUIRED SKILLS:

  • A Minimum of 2 years of Medical Device or other regulated industry (i.e. Auto, MIL, Aero, Defense) experience in a Mechanical, or Chemical Engineering, Configuration role or equivalent required. Pharmaceutical Industry experience beneficial

  • Experience preferably includes product or process design and development, including configuration management per ISO10007 (additional standards such as EIA649 and CMII beneficial)

  • The individual in this position possesses an intimate understanding of Design Controls, Configuration Management, and solid engineering expertise enabling them to guide the development of new products and design changes.

  • Must have experience with the Windchill/PTC Configuration Management tool. Experience with other software-based tools also beneficial (i.e. Agile, Eccentral, Arena, etc)

  • Excellent computer and writing skills.

  • Must have knowledge and understanding of Medical Device Regulation and Quality Assurance (e.g.) ISO9001, ISO 13485, ISO14971, IEC 60601; FDA 21 CRF820.30, ISO 10007.

  • Experience with identification of relevant compliance standards and associate testing

  • Demonstrated communication skills

  • Ability to communicate technical information to non technical audiences.

  • 2 – 5 years’ related experience; or an advanced degree without experience; or equivalent directly related work experience.

  • 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.

  • Experience with product or process design and development or quality engineering of sterile disposables utilizing various plastic processes such as injection molding and extruding.

  • Must possess an intimate understanding of Design Controls and solid engineering expertise enabling them to guide the development of new products and design changes.

  • Experience with development of Design Input and traceability through verification and validation V&V activities.

  • Experience with identification of relevant compliance standards and associate testing.

  • Demonstrated presentation and communication skills.

  • Strong oral and written communication skills. Ability to communicate technical information to non-technical audiences.

  • Proficient with PCs and Microsoft Office applications.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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