Fresenius Medical Care North America Sr. Mechanical Engineer - NxStage in Lawrence, Massachusetts
Job ID 21000P3G
Available Openings 1
PURPOSE AND SCOPE:
As a Sr. Mechanical Engineer, you will be largely unsupervised and self-motivated to lead mechanical engineering activities on development of a class II medical device. You will be responsible for all aspects of the mechanical design and integration from concept and feasibility all the way through production launch. Capable of receiving high level tasks and working independently to organize work, from required Cross Functional Teams (CFT) and to produce the final product or outcome assigned. You will be a team leader mentoring other engineers and designers and with potential for future growth. Additionally, you’ll support the roll-out of best practices at Fresenius Medical Care - NxStage and will be a resource for consulting on other projects and new technologies as needed.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Applies the education and experience to develop, maintain and resolve any issues with assigned systems of responsibility.
Subject matter expert role at all stages from converting lab scale technology into a commercial medical product to supporting the released product.
Define and implement mechanical and electromechanical system architecture in collaboration with other discipline leads
Is familiar with and follows FDA/ISO Design Control principles and regulations in product development.
Ensure similar challenges across different platforms are solved with similar, elegant solutions
Collaborate with systems, electrical, disposable, and software engineers to create, test, and improve complex electro-mechanical components and assemblies for next generation medical instruments. Components include pumps, motors, pneumatics, couplings, sheet metal housings, and PCBA mounting/cabling
Responsible for making independent technical decisions with minimal supervision
Analysis of mechanical systems, including geometric tolerancing and Finite Element Analysis for structural, fatigue, thermal, vibration, and acoustics
Develop manufacturing drawings in accordance with applicable standards
Troubleshoot new designs and/or develop reliability improvements for existing designs
Support the design, development, testing, and/or use of complex automated and semi-automated assembly and test equipment along with overseeing technicians in the construction of that equipment
Improve designs for reliability, manufacturability, and performance
Participate in the development of product specifications and requirements documents
Support and/or conduct Risk Analysis activities, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) to ensure design- and process- related risks are identified and appropriately mitigated
Work with Quality Assurance to maintain documentation in accordance with the approved internal Quality System that meets applicable GMP, QSR, ISO, and other requirements
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.
BS in Mechanical Engineering or related field with significant experience
MSME Strongly Preferred
EXPERIENCE AND REQUIRED SKILLS:
5+ years experience in electro-mechanical product design
Proven understanding of product and process development of medical devices is preferred
Advanced in SolidWorks 3D modeling, standard analysis tools and methodologies
Advanced understanding of molding, casting, rapid prototyping process
Experience with system design, electronics, mechanical and software integration
Proven knowledge of design of experiments is mandatory
Technical understanding of product development methodologies, design, and implementation
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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