FRESENIUS CORE VALUES:

Fresenius Medical Care is a people business. Our success depends on having the best and brightest employees, and helping them attain their personal and professional goals while delivering excellence in patient care and business results. Our employees embody our culture which is based on six core values supporting our promise to improve the quality of life of every patient every day. These core values are: Patients and Partners First, Honesty and Integrity, Quality and Compliance, Collaboration, No-Limits Mindset and Results Oriented.

PURPOSE AND SCOPE:

The Sr. Industrial Engineer possesses specific design knowledge to be a resource and key technical expert to support related projects. Ensures that all Industrial Engineering (Advanced Manufacturing Engineering) related aspects of the company products are addressed throughout the product development cycle and lead the design transfer efforts. The position will work closely with engineering, quality, procurement, logistics, risk, and manufacturing operations to support the design improvements and manufacturing of current and next generation products and focus on DF(x), where (x) stands for manufacturability, assembly, reliability, sustainability and refurbishability.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• 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.
• Applies the education and experience to develop, maintain and resolve any issues with assigned systems of responsibility. 
• Is familiar with and follows FDA/ISO Design Control principles and regulations in product development.
• Act as a Project Leader for major projects assigned (concept through release).
• Develops and establishes detailed Design (engineering) input specifications to ensure product function, minimized patient risk and cost effective manufacturing.
• Develops and maintains the documentation necessary to ensure the consistent manufacture of products (processes, drawings, and shop floor paperwork).
• Influence design for assembly accessibility and fabrication of all materials including plastic injection molding, machining, welding, etc.
• Provides engineering support for troubleshooting efforts for any process issues in designated area. Summarizes and draws conclusions from test results leading to effective technical resolution of process problems.
• Focus on planning and executing the transfer of products from design-to-production in a proactive and highly-collaborative manner
• Ensures design for manufacturing elements are incorporated into new product development activities.
• Identifies, justifies, and implements multiple significant data driven projects to reduce manufacturing costs, improve processes, increase product reliability, and enhance process capability.
• Designs and evaluates new and existing fixtures and equipment, test methods, specifications, layouts, and standards.
• Identifies and recommends manufacturing technologies to strategically develop business objectives and potential opportunities.
• Interfaces regularly with vendors/consultants based on responsibilities and assignments.
• Collaborates with manufacturing staff and management in other disciplines to develop, evaluate, and improve manufacturing methods.
• Conducts in-depth research to develop and introduce improved manufacturing methods. Analyzes assembly processes to ensure quality results are achieved and sustained. Analyzes data to determine return on investment.
• Works with production personnel, suppliers and contract manufacturers to establish or revise work instructions and production procedures.
• Ensures quality outcomes in device manufacturing areas by working with suppliers, quality systems, procurement and sustaining engineering.
• Performs hazard analysis on new equipment and systems to insure safe working conditions.
• Establishes validation protocols related to assembly and test processes.
• Design impact on Cost of Production (COP) reduction and recommend cost-saving measures
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• Provide mentoring and assistance to Engineer II and I level staff.
• Participate in "Corrective and preventive actions" regarding failure root cause analysis, solution development, and change assessment execution.
• Assist with various projects as assigned by a direct supervisor.
• Other duties as assigned.

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.
• Occasionally lift and/or move up to 25 pounds with assistance.
• Travel may requirement up to 10%.

SUPERVISION:

• None

EDUCATION:

• Bachelor’s Degree in related engineering or scientific discipline required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS:

• 5 – 8 years’ related experience; or a Master’s degree with 3 years’ experience; or a PhD with 1 year experience; or equivalent directly related work experience.
• Related experience in medical device preferred.
• Related experience in design for manufacturability and extensive experience with CAD software.
• Test protocol generation, execution, and reporting.
• Knowledge of current statistical and analytical methods.
• Knowledge of manufacturing documentation.
• Knowledge of design control and product development cycle
• Proficient in English and Spanish. German skills desirable

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.