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PURPOSE AND SCOPE:
Assists in the design of experimental protocol for R&D products that are applicable and acceptable to industry expectations/requirements. Coordinates with R&D to develop written specifications and applications data for new products. Write presentations based on this data for product introduction purposes.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Develops, analyzes, and writes test protocols, test results, product specifications, sub-systems requirements and Engineering Test Reports (ETRs) summarizing results from multiple experiments.
Tests and troubleshoots state-of-the-art electronic circuitry and complex pneumatic and hydraulic systems.
Leads exploratory testing to identify product and design deficiencies (software and hardware).
Participates in all phases of the product development cycle including hands-on involvement with fabrication, prototyping, and testing.
Contributes to generation of ideas and inventions to be used in new and existing products.
Sets up, adjusts, and operates laboratory equipment and instruments. Specific equipment familiarity depends on technical scope.
Assists with testing products for compliance and standards, acoustic testing, and altitude conformance.
Develops and revises Standard Operating Procedures (SOP's) and Test Methods (TM's).
Creates Change Notice (CN) and Deviation Notice (DN).
May act as an informal team leader and provides assistance to junior associate staff with support tasks that require considerable judgment and initiative.
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
May escalate difficult/complex issues to supervisor for resolution, as deemed necessary.
Supports RTG Marketing and Field Service. Travels to the location as needed to resolve the issues.
Supports GMQ Manufacturing Engineering, Quality, Failure Analysis, and Production on issues as needed.
Updates management on R&D support to the Field and Failure Analysis, Production, and Manufacturing Engineering.
Leads the Verification Team during phase I and Phase II of the project.
Assists with various projects as assigned by 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 50 lbs. with assistance.
SUPERVISION:
None
EDUCATION:
Associate’s Degree Required; Bachelor’s Degree Desirable
EXPERIENCE AND REQUIRED SKILLS:
6 – 10 years’ related experience.
Excellent oral and written communication skills
Knowledge of standard laboratory test and measurement equipment and tools.
Strong PC skills with Microsoft Office applications knowledge.
Ability to read engineering documentation (mechanical and electrical).
Familiarity with FDA standards including design control and managing design history file (DHF).
Familiarity with international standards.
Thorough understanding of HD and PD systems.
Highly motivated and energetic. Passion for creating high quality medical device software and systems.
Strong interpersonal skills with ability to work effectively in a team or individually with supervision.
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.