Sr Engineer (Software Test)

Fresenius Kabi USA, LLC; Suttons Mills (MA); Ibrido; USD 98.000 - 105.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) plan with company contributions

Paid vacation

Health benefits

Dental and vision coverage

Employee assistance program

Descrizione del lavoro

Fresenius Kabi USA, LLC in Massachusetts is seeking an engineering professional to design, build, and verify software test processes for medical devices, contributing to the validation and verification of software products.

The role offers a hybrid work arrangement (onsite 3 days/week) with a salary range of $98,000–$105,000 per year, plus a comprehensive benefits package including 401(k) contributions, vacation, holidays, health, dental, and vision benefits.

Competenze

• Bachelor's degree in Engineering, Computer Science, or related field preferred.
• Minimum 2 years in a regulated industry (medical device/pharma/ISO-FDA) preferred.
• Experience in medical device software development and testing preferred.
• Experience in a regulated industry preferred.
• Experience in Agile environments preferred.
• Experience with test case execution and reporting required.
• Experience designing and developing manual test cases for complex systems required.
• Excellent written and verbal communication skills.

Mansioni

• Defines and executes test cases for Ivenix Infusion System products and follows established testing procedures.
• Develops and maintains detailed documentation for internal and external customers.
• Traces test activities to system requirements and escalates findings per workflow.
• Works within a regulated environment and analyzes issues within defined parameters.
• Collaborates as an individual contributor and as part of a cross-functional team.
• Sets up and maintains test articles and fixtures and resolves routine issues.
• Participates in technical reviews and prepares project documentation.

Conoscenze

Test case execution

Software verification

Problem solving

Team collaboration

Verbal communication

Documentation

Formazione

Bachelor's degree in Engineering or CS

Strumenti

Selenium WebDriver

Squish

Python

VMware

Hyper-V

SQL

Windows Server

IIS/ASP.NET/Web Services

Descrizione del lavoro

Job Summary

An engineering position, under moderate supervision, participates in designing, building, and maintaining processes to test and verify software products used in medical devices and engineering projects related to medical technology. Applies standard engineering practices to resolve simple problems, and contributes to the validation and verification of software products.

Hybrid: Onsite 3 days per week

Salary Range: $98,000-$105,000 based on experience

• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

Defines and executes test cases for new and existing Ivenix Infusion System products. Following pre-established testing procedures. Ability to apply technical theories and principles. Accurately assess results for validity and conformance to specifications.

Develops and maintains detailed documentation for both internal and external customers. Traces test activities and results to system and subsystem requirements, escalating findings through the defined workflows.

Operates within defined processes and procedures consistent with a regulated environment. Works on problems of simple to moderate scope where analysis of situations or data requires a review of a variety of factors.

Effectively operates as an individual contributor and a member of the large team. Sets up and maintains test articles and test fixtures. Apply sound judgment to resolve routine and non-routine issues, follow established guidelines, and escalat when situations fall outside defined parameters.

Participates in technical reviews and is responsible for organizing data and preparing appropriate documentation for assigned projects.

Requirements

• Bachelor's degree in Engineering, Computer Science, or related field is preferred.
• Minimum 2 years of experience in a regulated industry (e.g., medical device, pharmaceutical, or other ISO/FDAgoverned environments) is preferred.
• Experience in medical device software development and testing is preferred.
• Experience working on a medical device or other regulated industry is preferred.
• Experience working in an Agile environment is preferred.
• Experience with test case execution and reporting is required.
• Experience in designing and developing manual test cases for complex systems and components is required.
• Excellent written and verbal communication skills.
• Thorough understanding of software test principles and best practices needed to produce high-quality software.
• Strong problem-solving and analytical skills.
• Proven ability to work collaboratively as part of a cross-functional team.
• Experience working in virtual environments. Experience with VMWare or Hyper-V is preferred.
• Experience testing devices with embedded Linux systems and/or platforms using IIS, ASP.NET, Web/Windows Services, and SQL is preferred.
• Experience with Windows Server administration, setup, deployment, and configuration, and the ability to interpret error logs are preferred.
• Proficiency with testautomation tools such as Selenium WebDriver, Squish, and Python is preferred.
• 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 atwill, 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.