R&D Systems Engineer

Reporting to the Engineering Manager, the R&D Systems Engineer will drive the integration of instrumentation to develop innovative high technology products for the human diagnostic market. The R&D Systems Engineer will develop and execute qualification procedures for complex fluidic, mechanical and optical instrumentation systems; and participate in designing and developing new diagnostic instrumentation.

Job Requirements

Responsibilities:

• Analyze, design, and test automated diagnostics instrumentation from a systems engineering perspective that include fluidic, mechanical and optics hardware components that, with company’s proprietary software, are able to run diagnostic test consumables.
• Work with scientists, engineers, and software developers across a wide range of specialty disciplines to design and execute study protocols for product integration and optimization.
• Write technical design documents according to set standards and guidelines within a regulated medical device quality framework.
• Design, develop and verify medical device scripts that connect and control third-party automated hardware components.
• Develop and execute verification and validation protocols and reports supporting current instrumentation system designs and design changes within the FDA, Health Canada and ISO 13485 regulations for design generation and design control.
• Integrates instrumentation development, design improvements and testing practices with the Software Development Team; manages these activities via electronic service tickets in 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, Mechanical, Mechatronics, or related Engineering field.
• Minimum 3 years’ experience in a regulated diagnostic, biotechnology or medical device company, preferably one with exposure to automation is a major asset.
• Programming experience in C, C#, or python 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
• Professional Engineer (P.Eng.) license is preferred

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.
• Experience with Fluorescence scanner qualification
• 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 Hamilton liquid handling platforms including creation of HSL libraries
• Experience utilizing source code control (SourceTree, git)

General Requirements

• Requires little instruction to execute work tasks
• Work tasks have a low degree of repetition and require planning prior to execution
• Work tasks have a moderate to high degree of complexity
• Requires little supervision/checking of work tasks by supervisor
• Percentage of independent work is < 60%
• May be responsible for leading people indirectly in a project/team environment