Staff Engineer, Systems Integration

• Assess design feasibility and test product functionality and/or confirm product capabilities.
• Responsible for test method development and lead V&V activities at the system level.
• Responsible for traceability of requirements to product design outputs.
• Participate in new product design and design improvements to existing products.
• Participate in the definition and creation of system architectures and documentation trees.
• Lead system integration activities during product design and V&V phases.
• Utilize Design of Experiment (DOE) as appropriate.
• Drives development and testing to assess performance against design specifications.
• Participate in Human Factors Engineering/Usability Engineering tasks and activities.
• Strong analytical and problem-solving skills.
• Establish interfaces across other organizational groups.
• Work independently to apply technical expertise to lead efforts in system design, implementation, integration, and verification and validation (V&V) of medical devices and products.
• Participate in requirements management activities involving creation, decomposition, and traceability of requirements.
• Prepare and deliver presentations of project results to others; present data to larger and more diverse audiences.
• Participate in the evaluation and assessment of competitive products, processes, and/or new trends.
• Engage with the Original Equipment Manufacturer (OEM) to provide technical oversight and guidance on evolution of the design.
• Collaborate with hardware, software, and reagent team members to develop and implement product designs.
• Ensure the necessary documentation for V&V activities are included in the project Design History File (DHF).
• Assist in the development of manufacturing processes and troubleshooting issues to determine root cause and possible engineering solutions.
• Collaborate with cross-functional teams to ensure all development activities are conducted in adherence to applicable national/international regulations, guidelines, company policies, SOPs, and industry standards.
• Participate in product risk management activities involving system Hazard Analysis (HA) and Failure Modes and Effects Analysis (FMEA).
• Participate in project planning, process updates, design reviews, and contributes to experimental design.
• Utilize integration, analytical, and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system issues.
• Apply working knowledge of DOE, analysis and interpretation of test results, failure investigation, and root cause failure analysis.
• Uphold company mission and values through accountability, innovation, integrity, quality, 

• Support and comply with the company’s Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to work nights and/or weekends.
• Ability to lift up to 25 pounds for approximately 5% of a typical working day.
• Ability to work seated for approximately 75% of a typical working day. Ability to work standing for approximately 25% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to perform repetitious actions using lab tools and equipment.
• Ability and means to travel between Redwood City locations.
• Ability to travel 15% of working time away from work location, may include 
• overnight/weekend travel.

• Bachelor’s degree in Biology, Biochemistry, Systems Engineering, Biomedical Engineering, Physics, or related field.
• Authorization to work in the United States without sponsorship.
• 10+ years of relevant experience, including previous hands-on involvement as an engineer, scientist, or product developer working through a formal phase gate or new product development process in the IVD medical device industry (e.g., System Integration Engineer, System Development Engineer, or related occupation).
• Solid technical writing skills to produce reports and documents; writes independently; evaluates the writing of others.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

• Experience with instrument automation or scientific instrumentation.
• Six Sigma certification.
• Design for Six Sigma (DFSS) experience.
• Proficiency with formal requirements management tools.
• Advanced degree (Masters / PhD) in Biology, Biochemistry, Systems Engineering, 
• Biomedical Engineering, Physics, or related field.
• Experience with next generation sequencing, immuno-histochemistry, in-situ hybridization, PCR, methylation.
• Experience with system analysis, model-based system engineering, and system 
• architecture

In specific locations, the pay range may vary from the range posted.