Sr Design Assurance Engineer - Fresenius Medical Care Holdings, Inc.

PURPOSE AND SCOPE:

Participate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control process. Utilize technical training and compliance experience to ensure that company design control projects comply with internal design control procedures in accordance with FDA and ISO requirements.

PRINCIPAL DUTIES AND RESPONSIBILITIES:  

• A seasoned, experienced professional with a full understanding of design control process; resolves a wide range of issues in creative ways.

• Responsible for assuring projects meet customer expectations, and regulatory requirements.

• Provide guidance to engineering staff and other personnel and ensure that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.

• Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF for accuracy and completeness and provide guidance on FDA compliance and procedures.

• Review and approve design control related Change Notices (CNs) within the documentation system.

• Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards.

• Represent the design quality functions for the review and approval of designated design outputs.

• Assist in the development and maintenance of company procedures for design control, change managements, risk management, process validation and related areas of the quality management system.

• Represent the design quality assurance department to FDA, ISO and all other auditors.

• Work independently on high visibility new product development projects; including projects involving multiple technologies and design sites.

• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.

• May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.

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

• Mentor other staff as applicable.

• Assist with various projects as assigned by a 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.

• Ability to life and/or move up to 50 lbs. with assistance.

EDUCATION:

• Bachelor's Degree required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS:        

• 5 - 8 years' related experience; or a Master's degree with 3 years' experience; or a PhD without experience; or equivalent directly related work experience.

• Familiar with critical elements of the design history file including risk management, design verification and validation tests and ensuring compliance of these elements to procedural requirements.

• Ability to multi-task and operate within a fast-paced environment.

• Strong organizational and presentation skills required.

• Excellent oral, written, analytical, computer and interpersonal skills.

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

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.