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. 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.

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 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