Mechanical Engineer II

PURPOSE AND SCOPE:

The Mechanical Engineer II will play a key role in improving our Home HD products and our patients' lives. This individual will apply sound engineering principles in the support of our current product portfolio and will be involved in different parts of a product's life, including but not limited to the feasibility evaluation for new features and products to improve the quality, performance, and cost of dialysis therapy. You will be part of a team with responsibility for supporting a specific product line. Close collaboration with manufacturing, quality, regulatory, and product management counterparts is key to quickly responding to issues, completing projects, and launching new products.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• 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

• Construct and test / oversee technicians in constructing and testing of prototype systems

• Troubleshoot new designs and/or develop reliability improvements for existing designs

• 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, ISO13485, and other requirements

• Support the design, development, testing, and/or use of complex automated and semi-automated assembly and test equipment

• Manage vendors to ensure rapid delivery of prototype components

• Create, test, and improve complex electro-mechanical components and assemblies for next generation home dialysis instruments. Components include pumps, motors, pneumatics, couplings, sheet metal housings, and PCBA mounting/cabling

Skills:

• Proficient in Solidworks 3D modeling, standard analysis tools and methodologies, mechanical detailing, geometric tolerance analysis, and documentation is preferred

• Strong understanding of medical device development processes

• Able to communicate effectively, both verbally and in writing

• Strong diagnostic & problem-solving skills desired, including troubleshooting and root cause analysis

• Experience maintaining the confidentiality of sensitive information

• Experience with design of experiments

• Familiarity with fabrication methods such as machining, molding, sheet metal, and casting processes

• Demonstrated aptitude for practical application of mechanical, pneumatic, and electrical principles to system design.

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.

EDUCATION:

• Bachelor's Degree in Mechanical Engineering preferred.

EXPERIENCE AND REQUIRED SKILLS:

• 2+ years of experience in product design, development, and/or testing of complex electro-mechanical products preferred
• Prior medical device experience strongly preferred

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.

If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form (smartsheet.com)