San Diego, CA
Industry: Pharmaceuticals & Biotech•
5 - 7 years
Posted 163 days ago
BioTelemetry Technology, a BioTelemetry Company, (NASDAQ: BEAT) provides medical devices and software for real-time remote heart monitoring and analysis using our own innovative solutions. Come join our team and have a direct and positive impact on the lives of people every day! We want YOU to help us create the future of medical devices with the industry leader!
We are looking for a highly energetic and motivated Systems Verification Engineer. The Systems Verification Engineer has the exciting opportunity to have a significant impact to the Company. The successful candidate will have a unique blend of technical knowledge, as well as exceptional communication and problem-solving skills. This role includes evaluating and calibrating the equipment and procedures used in development and production of various BioTelemetry products, tools/testers, and related software products.
The ideal candidate will demonstrate a system-level focus while understanding the impact of every component. The ideal candidate will also have experience with establishing validation standards, developing test protocols/test cases, preparing equipment, oversee the execution of verification and validation testing activities, document test results, and maintaining records in a medical device manufacturing organization. The successful candidate will need to be familiar with medical device industry standards and regulatory guidelines.
· As a team player, collaborate with other Quality Engineers to define, schedule and execute testing in a manner that will lead to the discovery of high cost or high risk issues early in the development process.
· Drive continuous improvement activities relating to test design, planning, execution and reporting.
· Review, revise/improve or introduce new validation practices that will have a positive impact to the development and production of quality products and services.
· Work with the automation Quality Engineering team on ways to automate repetitive and high-risk testing scenarios where possible.
· Collaborate with other product development teams to ensure integration risks are well understood and properly tested.
· Ensure that devices and tools are calibrated and updated regularly.
· Responsible for documenting defects.
· Responsible for creating detailed test cases and scripts, validating that the requirements are captured correctly with the Business Analyst or Product Owner.
· Perform verification testing and analysis of test results to confirm complete verification of the requirements.
· Provide Engineering support to other teams when needed.
· Create required test data and test deliverables as per testing standards.
· Works with the development team to analyze and resolve defects.
· Minimum BS degree in Computer Science, Computer Engineering, Electrical Engineering, Mechanical Engineering or related field.
· Minimum of 5 years experience in performing Quality Engineering activities.
· Minimum of 5 years experience in a Systems Verification Engineering or related role.
· Experience working with manufacturing, development and production teams or groups.
· Good communications and documentation skills, including experience in writing SOPs, work instructions, training and other relevant documentation.
· Must work well in a team environment, be highly motivated, and willing to learn new skills.
· Previous experience with testing in a medical device manufacturing environment subject to FDA compliance is a plus.
· Proficient with Microsoft Office.