Senior Engineer, Software HIT

Fresenius Kabi USA

Sr Engineer (Software HIT) developing software applications for medical technology at Fresenius Kabi. Analyzing and resolving engineering challenges in compliance with medical product design controls.

Posted 7/24/2026full-timeNorth Andover • Massachusetts • 🇺🇸 United StatesSenior💰 $115,000 - $135,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in software engineering processes, including design, development, and documentation of medical software applications. Proficient in .NET technologies, problem-solving, and compliance with FDA regulations.

Highest-signal resume keywords

Software Development Life-Cycle MethodologyC# Programming.NET Framework / .NET CoreMedical Device Development ProcessesAutomated Testing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Software EngineeringRoot Cause AnalysisObject Oriented Design PatternsWeb Application DevelopmentSQL ServerHTTP ProtocolSOAP ProtocolREST ProtocolAutomated TestingConfiguration Management

Soft Skills

Problem SolvingAnalytical SkillsAttention to DetailCollaborationMentoring

Tools & Technologies

VMWareAWSAzureGitBitbucket

Industry Keywords

Medical Product Design ControlsFDA RegulationsDesign Control ProcessTechnical DocumentationSoftware Development Best Practices

Tech Stack

Tools & technologies

AWSAzureCloudEntity Framework.NETSOAPSQLVMware

About the role

Key responsibilities & impact

Analyze, plan, design, execute, and document software applications and/or processes within established medical product design controls.
Design and develop software adhering to product requirements, definitions and/or program goals.
Apply standard techniques and resolve moderate to high complexity problems/defects, performing root cause and failure analysis.
Display a solid understanding and ability to apply technical theories/practices utilized by own discipline and other disciplines outside the primary area of expertise to identify coverage of risks, requirements, architectural components, functions, and performance.
Work with senior leadership to improve software engineering process efficiency.
Perform code reviews to confirm software implemented to approved designs, specifications and meet quality standards.
Assist with project timing, tracking progress to program schedule.
Recognize and identify improvements for software engineering process deficiencies and software development best practices.
Mentor and guide junior staff, routinely provide advice and assistance to team members regarding routine and unique problems.
Work with internal and external staff to conduct design, redesign, prototype, and other software engineering activities.
Author and review software specifications compliant with design control process.
Develop and maintain technical records and detailed documentation for internal and external stakeholders, following standard practices and good documentation procedures.

Requirements

What you’ll need

Bachelor’s degree in Engineering is required, Information Technology or related field is preferred.
5+ years of experience in software engineering, troubleshooting, and solving problems.
Experience in the software development life-cycle methodology and verification of software product implementation.
Experience of medical device development processes and FDA regulations a plus.
Demonstrated experience in designing and implementing performant system software solutions using a variety of .NET technologies.
Demonstrated experience in using Object Oriented design patterns in multi-tiered and multi-layered architectures.
Experience with C#, .NET Framework / .NET Core, Web Application Development, Windows and Web Services and SQL Server is required.
Experience with HTTP, SOAP, and REST protocols is required. Experience in internet networking design architecture for real-time communications is a plus.
Experience with various types of automated testing such as Unit, Integration, System, Performance, Load/Stress, Regression is desired.
Experience working in the virtual and cloud environments is required. Experience with VMWare, AWS/Azure desired.
Ability to diagnose and solve problems involving multiple technologies (i.e., front end web clients, C#, Entity Framework, SQL)
Knowledgeable in source control management and configuration. Experience with Git/Bitbucket desired.
Ability to work as a collaborative team member.
Strong in problem solving, analytical and debugging skills.
Attention to details, natural inclination to be methodical.
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.

Benefits

Comp & perks

401(k) plan with company contributions
Paid vacation
Holiday and personal days
Employee assistance program
Health benefits including medical, prescription drug, dental, and vision coverage