Senior Systems Engineer
4 days ago
We are seeking a highly motivated and experienced Systems Engineer to join our team at Fresenius Medical Care North America. As a key member of our R&D team, you will be responsible for designing and developing experimental protocols, coordinating with R&D to develop written specifications and applications data for new products, and writing presentations based on this data for product introduction purposes.
Key Responsibilities- Develop, analyze, and write test protocols, test results, product specifications, sub-systems requirements, and Engineering Test Reports (ETRs) summarizing results from multiple experiments.
- Test and troubleshoot state-of-the-art electronic circuitry and complex pneumatic and hydraulic systems.
- Lead exploratory testing to identify product and design deficiencies (software and hardware).
- Participate in all phases of the product development cycle, including hands-on involvement with fabrication, prototyping, and testing.
- Contribute to the generation of ideas and inventions to be used in new and existing products.
- Set up, adjust, and operate laboratory equipment and instruments, with specific equipment familiarity depending on technical scope.
- Assist with testing products for compliance and standards, acoustic testing, and altitude conformance.
- Develop and revise Standard Operating Procedures (SOPs) and Test Methods (TMs).
- Create Change Notice (CN) and Deviation Notice (DN).
- Associate's Degree Required; Bachelor's Degree Desirable.
- 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, with a passion for creating high-quality medical device software and systems.
- Strong interpersonal skills, with the ability to work effectively in a team or individually with supervision.
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.
EO/AA EmployerFresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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