R&D Systems Engineer

Reporting to the Engineering Manager, the R&D Systems Engineer will drive the integration of instrumentation to develop innovative products for the human diagnostic market.The R&D Systems Engineer will develop software solutions to integrate robots with automated medical devices. The successful candidate will work with other R&D Systems Engineers and software developers to design and implement critical automation support for high-throughput screening, assay development, sample management, and lab automation solutions.Job RequirementsResponsibilities:Develop and optimize new liquid handler protocols for the screening and high-throughput assay platforms, specifically using Hamilton Venus.Analyze, design, and test automated diagnostics instrumentation from a systems engineering perspective that includes liquid handling and Fluorescens scanner devices that, with the company’s proprietary software, are able to run diagnostic test consumables.Write technical design documents according to set standards and guidelines within FDA, Health Canada, and ISO 13485 regulations for design generation and design control; develop and verify medical device scripts that connect and control third-party automated hardware components.Integrate instrumentation development, design improvements, and testing practices with the Software Development Team; manage these activities via Atlassian tools for version control (Bitbucket) and issue management (Jira).Investigate and resolve reported system issues within the Quality Management System (CAPAs, customer complaints, deviations, etc). This may include conducting root cause analyses and risk assessments; planning and executing corrections and corrective/preventative actions; writing investigation reports; initiating Supplier Corrective Action Reports (SCARs).Education, Qualifications, and Requirements:Undergraduate degree in Systems, CS, Mechanical, Mechatronics, or related Engineering field.Minimum 1 year experience in biotechnology or medical device company, preferably with experience integrating automated medical devices.Proven programming experience in C, C#, Python, and JAVA is required.Knowledge of CAD and instrumentation design.Ability to create documentation (e.g., verification and validation protocols) within a Quality Management System, and ability to analyze and summarize experimental data.Other Required Skills:Strong work ethic and organizational skills; highly motivated; conscientious; ability to work both independently and as a team player.Excellent oral and written communication skills.Defining and interpreting technical requirements and specifications for new/next-generation instruments – especially in areas related to controls, firmware, and software.Ability to effectively collaborate with programmers, engineers, scientists, and production management during the entire life cycle of system development.Willingness to learn new skills and attention to detail.Experience programming liquid handling such as Hamilton liquid handling platforms, including creation of HSL libraries, or TECAN or PerkinElmer.Experience with robotic programming.Experience utilizing source code control (SourceTree, git).General RequirementsWork tasks have a low degree of repetition and require planning prior to execution. Work tasks have a moderate to high degree of complexity. #J-18808-Ljbffr