Job Summary

Responsibilities

• Develop and execute protocols for the evaluation of changes to electro-mechanical devices. 
• Analyze and propose design changes to assemblies and components for cost savings and quality improvements on hardware devices.
• Utilize engineering principles, technical analysis, computational analysis, and problem-solving tools to resolve testing, field, and manufacturing product issues.
• Evaluate part obsolescence and support requalification efforts for electrical components .
• Maintaining design requirements, design specifications, and risk management documentation; performing electrical testing; supporting verification and validation activities.
• Executing design changes thru design change control and document control processes

Please note: This position cannot provide employment-based immigration sponsorship now or in the future. Applicants must be currently authorized to work in the United States for any employer and must be able to maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time, including in the instance when your current work authorization expires. We ask that candidates answer all work authorization questions fully and accurately during the application process.

This job position within the MedTech division of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).

REQUIREMENTS

• Bachelors degree in Electrical Engineering with 3-5 years of relevant experience in embedded design.
• Experience with electrical design tools: Altium, Pspice, oscilloscopes, signal generators, etc.
• Experience with troubleshooting hardware and software issues
• Familiar with appropriate FDA QSR and ISO regulations:  design controls, document controls, design verification and validation, hazard analysis techniques, regulatory approval methods, and overall medical device industry knowledge. 
• Must possess a firm foundation in the basic principles of their respective engineering discipline.
• Strong critical thinking skills and the ability to function in a sometimes-ambiguous situations.
• Excellent verbal and written communication skills.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.