Title: Senior Systems Integration Engineer
Location: Norcross, GA
The Senior Systems Integration Engineer proactively leads and contributes to multiple moderate to complex projects and design changes in support of development and
investigations. Responsible for developmental activities as well as design verification and validation related to products, assays, software and hardware.
Key Accountabilities
• Identify testing plans for integration of new hardware components, assays, software, and products
• Lead efforts developing strategies for assay, software, hardware integration
• Lead team to evaluate/ perform functional testing on new hardware/software/reagent
• Evaluate/ perform functional testing on new analyzers and/or new configurations to support product development activities and make decisions towards defining parameters
• Design experiments using DOE methodology and analyze the test results using statistical tools. Interpret the results correctly and provide feedback effectively for design improvements.
• Perform advanced troubleshooting on the automated systems
• Represent the Verification team on project core teams
• Perform statistical and verification data analysis at an advanced level
• Develop Verification Protocols to assure Requirements and Specifications are fulfilled
• Review results of executed Protocols and write summary reports and provide conclusions
• Anticipate the needs of the project and react to them accordingly without direction
• Perform traceability analysis of test protocol to Requirement
• Maintain adherence to PDP and GDP
• Write and execute moderately complex system related development and/or characterization protocols and data packages.
• Review and approve verfication and validation protocols and reports, as assigned
• Manage execution of verification and validation protocols
• Review technical risks and take appropriate action
• May assist in developing SHA and FMEA for Risk Management
• Support moderately complex investigations of system issues
• Presents, delivers and interprets information amongst product team members, scientists, engineers, and other systems development personnel
• Additional task assigned as needed to support ongoing integration projects related to product, assay, software and hardware
Networking/Key relationships
Works closely with Systems Engineering, Quality, Regulatory, Assay Development, and
occasionally Marketing and Clinical teams.
Minimum Knowledge & Experience required for the position:
• Master's Degree (MA); or equivalent combination of education and experience
• Four to ten years of related work experience.
• Experience in IVD development
• Science or Engineering Degree Preferred
Skills & Capabilities:
Excellent written and verbal communication skills.
Excellent analysis, troubleshooting, and debugging skills.
Ability to perform in a fast-paced, agile environment.
Ability to operate independently and exercise good judgment
Understanding of technical content and the ability to communicate well with subject matter
expert
Works well with others in a collaborative, goal-driven environment
...restaurants, unique retail shops and a state-of-the-art convention center. We are inviting you to apply for our open Resort Assistant General Manager position. In this role, you run the resort on a day-to-day basis to achieve stated objectives in employee retention, guest...
Top 3 Must Have skillsets: o DFMEA o FMEA o DFM and PLUTO The job description for a DFMEA, PFMEA, and DFM expert in an automotive Tier-1 company involves several key responsibilities and qualifications. The expert will be responsible for developing and implementing...
...Door Installation Foreman Starting Wage: $33-$40/ HR DOE Earning potential of $70,000-$100,000 annually Are you interested in a career change with a small organization on the grow? We are looking for individuals to join our team to assist in the servicingof...
...best and the brightest to be a part of our team. When you can... ...serves meals in a friendly and timely manner. Assures resident/guest... ...and training of new food servers. Practices all safety and... ...Computer skills required: Order Processing Systems If you want to...
...AmeriCorps Recruitment and Operations Manager College Possible Office in Seattle This Work Is Our Mission At College Possible, we believe talent is universal. For many students, the path to college can feel overwhelming or out of reach. That's where you come...