Sr Engineer (Electrical)

RXinsider LTD.; Northern (KY); Hybrid; USD 85,000 - 96,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi is seeking a Senior Electrical Engineer in Kentucky to manage life-cycle engineering for on-market infusion pump systems. You will work with cross-functional teams including manufacturing, quality and regulatory to ensure robust hardware development.

The role requires a B.E. in Electrical Engineering with 3-5 years of embedded design experience, hands-on tools like Altium and Pspice, and familiarity with FDA QSR/ISO regulations.

Qualifications

• Bachelor's degree in Electrical Engineering.
• 3-5 years of embedded design experience.
• Experience with Altium, Pspice, oscilloscopes, signal generators.
• Familiar with FDA QSR and ISO regulations in medical devices.

Responsibilities

• Develop and execute protocols for evaluating changes to electro-mechanical devices.
• Analyze design changes to assemblies for cost savings and quality improvements.
• Use engineering principles and analyses to resolve testing, field, and manufacturing issues.
• Evaluate part obsolescence and support requalification of electrical components.
• Maintain design requirements, specifications, risk management docs; perform electrical testing; support verification/validation.
• Execute design changes through change control and document control processes.

Skills

Troubleshooting hardware and software

Education

Bachelor's degree in Electrical Engineering

Tools

Altium

Pspice

Oscilloscopes

Signal generators

Job description

Job Summary

********** SIGN-ON BONUS ***********

Salary Range: $85,000 to $96,000 Per Year dependent on education and experience.

The Senior Engineer performs Electrical Engineering tasks for the life-cycle management for on-market Infusion Pump system. Requires working in a team environment with cross-functional team members, such as manufacturing, quality, regulatory, and other R&D departments.

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.

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.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

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, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.