Process Engineer focused on process support activities to meet departmental goals for a global medical technology company. Responsibilities include troubleshooting mold setting and supporting capital improvement projects.
About the role
- Senior Engineer (Software Test) responsible for designing, building, and maintaining software test processes for medical technology. Collaborates on Ivenix Infusion System ensuring compliance in a regulated environment.
Responsibilities
- Define and execute test cases for new and existing Ivenix Infusion System products.
- Follow pre-established testing procedures.
- Accurately assess results for validity and conformance to specifications.
- Develop and maintain detailed documentation for both internal and external customers.
- Trace test activities and results to system and subsystem requirements, escalating findings through the defined workflows.
- Operate within defined processes and procedures consistent with a regulated environment.
- Work on problems of simple to moderate scope where analysis of situations or data requires a review of a variety of factors.
- Effectively operate as an individual contributor and a member of the large team.
- Set up and maintain test articles and test fixtures.
- Apply sound judgment to resolve routine and non-routine issues, follow established guidelines, and escalate when situations fall outside defined parameters.
- Participate 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/FDA‑governed 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 test‑automation tools such as Selenium WebDriver, Squish, and Python is preferred.
Benefits
- 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
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