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 Engineer and software developers to design and implement critical automation support for high-throughput screening, assay development, sample management, and lab automation solutions.
Job Requirements
Responsibilities:
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 include liquid handling, Fluorescens scanner Devices that, with company’s proprietary software, are able to run diagnostic test consumables.
Write technical design documents according to set standards and guidelines within a 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.
Integrates instrumentation development, design improvements and testing practices with the Software Development Team; manages 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 the following activities: 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 years experience in biotechnology or medical device company, preferably one ; experience with integrating automated medical devices is a major asset.
Proven Programming experience in C, C#, python, 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.
Requires excellent oral and written communication skills.
Defining and interpreting technical requirements and specifications for new/next-generation instruments – especially in all areas related to controls, firmware and software - often starting with limited input
Ability to effectively collaborate with programmers, engineers, scientists, and production management during the entire life cycle of system development.
Willingness to learn new skills, 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 Requirements
Work tasks have a low degree of repetition and require planning prior to execution
Work tasks have a moderate to high degree of complexity
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