Fresenius Medical Care North America Sr. Design Assurance Engineer - NxStage in Lawrence, Massachusetts
Job ID 21000CMQ
Available Openings 1
PURPOSE AND SCOPE:
As a key member of the Design Assurance Group, the engineer will support the activities related to the design, development, and maintenance of electromechanical medical devices that also contain software and have functions requiring the use of associated disposable medical products.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Provides quality oversight and guidance for medical device Design and Development and release to production.
Review deliverables of the development lifecycle for correctness and compliance to policies and procedures. Includes design and development plans, design input requirements, risk management, human factors, design reviews, design outputs, design changes/configuration management, design verification and validation, and design transfer deliverables.
Lead root cause analysis activities to resolve Design Quality-related problems.
Lead/support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed. Develop risk management plans, develop/support development of risk analyses such as Hazard Analyses, Fault Tree Analysis, FMEAs. Develop/maintain risk management reports.
Develop/support development of Post Market Surveillance Plans.
Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies
Strong analytical and problem-solving skills, ability to multitask in an environment with changing priorities.
Working knowledge of statistical techniques/tools. Working knowledge of process validation and test method validation.
Investigate/reproduce customer problems/issues.
Work with other Groups to maintain an approved internal Quality System that meets medical device quality system regulations and standards, in particular the Design Control and Risk Management aspects.
Support CAPA investigations and other quality activities as needed.
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.
- Bachelor's Degree in Mechanical, Electrical, Biomedical or similar Engineering field.
EXPERIENCE AND REQUIRED SKILLS:
5+ years related Design Assurance/Quality Engineering/Medical Device Product Design experience
Working knowledge of FDA Quality System Regulation 21 CFR Part 820, EU MDR, ISO14971, IEC62366, IEC60601-1, and ISO13485 required.
Excellent verbal communication, presentation, and technical writing skills.
Ability to interface with multiple groups in the organization.
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.
Fresenius Medical Care North America
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