- Disciplined and detail-oriented; deliver robust, readable test documentation.
- Key contributor for software manufacturing test solutions: IQ, OQ, and PQ
- Document automation solutions for production: requirements, test plans, protocols, and reports.
- Engage in the software test lifecycle for medical devices; knowledge of standards: GAMP 5, FDA GMP
- Experience with FDA regulations for software validation and 21CFR compliance
- Ensure that all test activities are conducted in accordance with Quality System procedures
- Assist with the creation and review of test operating procedures, work instructions, and forms.
- Determination and sound technical judgment in problem solving, analytical techniques, develops new / creative test designs, and can work independently with little supervision
- Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job.
- Performs additional duties as assigned.
- Position requires a BS in Information Systems or related technical field (e.g. Computer Science, Biomedical Engineering, Physics) with a minimum of 7 years medical device test experience or relevant experience and training. Attention to detail, organization, and data analysis skills are required. Working knowledge of Microsoft Word and Excel are required. Must be able to work in a fast pace environment, multi task, and have good communication skills, both verbally and in writing.
- Solid knowledge of software test and development cycle
- Solid Knowledge of quality assurance methodologies.
- Experience writing plans, procedures, reports, and executing integration tests on hardware and manufacturing equipment.
- Experience testing various software including but not limited to web applications, API services, and PC applications
- Creates system requirements, specifications, user manuals, or other technical publications.
- Familiarity with off the shelf test automation tools (e.g. TestComplete, Ranorex, Squish)
- Proficient and demonstrable skills in a programming languageWorking Knowledge of C#/.NET and/or Python
- Working knowledge of LabVIEW a plus
- Ability to work within an agile test development environment
- Familiarity with version control systems (git) and release methodologies
- Familiarity with continuous integration (Jenkins)
- Skills in problem solving; including the ability to identify and appropriately evaluate a course of action.
- Ability to pay attention to details and perform at a high level of accuracy.
- Ability to work independently and with a team.
- Prepares complex data sets to test logic, error handling and system workflows.
- Isolates, reproduces, and tracks defects. Verifies fixes.
- Respond to non-trivial Tech Support inquiries or complaints from customers.
- We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one
- We invest in our employees' financial futures through 401k matching and an employee stock purchase plan.
- We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.
- We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
- We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
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Senior Software Quality Engineer - Wallingford, United States - Bio-Techne
Description
Job DetailsLevel
Senior
Job Location
Wallingford CT - Wallingford, CT
Position Type
Full Time
Education Level
Bachelor's Degree
Travel Percentage
Negligible
Job Shift
Day
Job Category
Quality & Regulatory
Description
By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Position Summary:
ProteinSimple is part of the Protein Platforms division of Bio-Techne (NASDAQ: TECH). We're rethinking protein tools and helping thousands of researchers around the world resolve their protein analysis problems so they can reveal new insight into proteins and their role in disease. Software is vital to our success in developing award winning bio-tech instruments for the life sciences industry. Our product development team is making products that are drastically changing how scientists and researchers use tools to become more productive. Use your strong knowledge of quality assurance to expand the reliability of our instrument systems. You will collaborate with other engineers and scientists in the production of manufacturing applications, working with test automation designs, device communications, and complex data workflows. We are offering an opportunity to work with state of the art software/hardware technologies amongst a very creative, motivated, and talented team.
This position is responsible for the design and execution of test solutions to verify protein analysis products as a medical device. Interfaces closely with other disciplines on project teams to ensure a seamless transition through software life cycle and that testing is comprehensive with respect to regulatory standards. Participates in creation software requirements and provides up-front feedback on requirements testability.
Perform additional duties as assigned.
ESSENTIAL FUNCTIONS
Education and Experience:
Bio-Techne is an E-Verify Employer in the United States.
