PURPOSE AND SCOPE:

The Sr. Mechanical Engineer is seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. Acts as a subject matter expert to design and analyze mechanical systems, equipment and packaging. Conducts feasibility studies and testing on new add modified designs. Directs support personnel in the preparation of detailed design, design testing and prototype fabrication. Provides design information to drafting for packaging documentation.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Performs development and detailed design of mechanical components and specifications for electro-mechanical medical devices.
• Leads design control projects, including writing design verification and validation protocols and reports and risk analysis.
• Develops/designs/sustains mechanical fixtures for assembly and testing
• Participates in root cause investigations for Non Conformance Reports and CAPAs.
• Drives process improvement and cost savings projects
• Drives equipment qualifications, test method development and validations and process validations
• Provides weekly status on engineering schedule, progress, and issues. Responsible for the quality and content of engineering deliverables.
• Works creatively, efficiently, and effectively with cross functional teams and manufacturing groups.
• Leads DFM and NPI projects.
• Responsible for making independent engineering decisions without any supervision.
• Mentors other staff as applicable.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Networks with senior internal and external personnel in own area of expertise.
• Normally receives little instruction on day-to-day work, general instructions on new assignments.
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
• Assists with various projects as assigned by a direct supervisor.
• Other duties as assigned.

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.
• Occasionally lift and/or move up to 50 pounds with assistance.

EDUCATION:

Bachelor's Degree or advanced degree in Mechanical Engineering or related field.

EXPERIENCE AND REQUIRED SKILLS:

• Minimum 5 - 8 years of related mechanical design engineering experience; or a Master's degree with 3 years of experience.
• Experience and understanding of engineering materials, plastic manufacturing processes, adhesives, metal manufacturing processes, rapid prototyping
• Experience in solid modeling and developing drawings with Solidworks including tolerance analysis and ability to understand and apply ANSI standards to drawings.
• Personal experience in development and verification of high quality mechanical subsystems.
• Understanding of material science, thermodynamics and fluid dynamics.
• The position requires excellent organizational and communication skills and a proven track record managing significant portions of projects independently.
• Previous experience working with Labview/COMSOL/ANSYS and mechanical reliability testing experience would be a plus.
• Candidate must have experience with design control requirements, including risk analysis.
• Candidate must have experience in DFM and NPI.

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.