Position Summary:As a Sr. Mechanical Engineer, you will 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 and sustaining activities. You will be a leader mentoring other engineers and with potential for future growth. Additionally, you’ll support the roll-out of best practices at Fresenius Medical Care and will be a resource for consulting on other projects and new technologies as needed.Responsibilities:
Champion major projects, or phases of projects, to resolve advanced and complex technical problems
Mentor the product development team in the adoption and use of best practices and design methodologies
Define and implement mechanical and electromechanical system architecture in collaboration with other discipline leads
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 without any 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
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.
EDUCATION:
Bachelor’s Degree in Mechanical Engineering or scientific discipline required; Advanced Degree preferred.
EXPERIENCE AND REQUIRED SKILLS:
5+ years experience in electro-mechanical product design
1+ years experience as technical lead, mentoring other engineers
Proven understanding of product and process development of medical devices is preferred
Advanced in CREO and/or SolidWorks modeling, standard analysis tools and methodologies
Advanced in FEA with Ansys (mechanical. structural, thermal)
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
Proven knowledge of design for six sigma methodology is welcome
Technical understanding of product development methodologies, design, and implementation