The Senior Systems Engineer will focus on complex product design, intellectual property development, problem solving, risk reduction, system verification and documentation for development of bioprocess equipment and sterile consumables for the pharmaceutical industry. He/she is responsible for leading the integration of all mechanical, electrical, consumable (e.g. plastic) and automation subsystems for successful development.
- The Systems Engineer will be responsible for coherence and compliance of the system development with systems engineering principles and processes.
- Accountable for the system integration of subsystems for new bioprocessing equipment and consumables such as in the Xcellerex, WAVE, and ReadyToProcess product lines.
- Lead through engagement, collaboration and indirect influence of cross-functional resources to obtain consensus, while connecting with people empathetically, energizing and motivating your teammates, and inspiring them to work toward the project goals.
- Create platform design aligned to long-term technology roadmap.
- Develop architecture viewpoint, relate the architecture to design and remove ambiguity, and manage selected architecture while communicating clear outlines of system architecture and function.
- Support technical scope definition, VOC and user experience (UX) activity, intellectual property development, risk retirement & feasibility prove-out.
- Lead requirement management across cross-functional team from product inception through commercial launch.
- Perform functional analysis, work cross-functionally, and apply creativity to resolve problems when presented with conflicting requirements, business demands and technical risks/issues.
- Address implementation complexity, risks, manufacturability, serviceability and quality.
- Foster inclusive design review process to reduce risk, ability to do trade-off analysis with program metrics (e.g. cost, schedule), and ensure continued alignment with business.
- Architect system verification & validation strategy, manage and lead defect resolution, trace matrix, and support design transfer.
- Maintain compliance with design controls, program documentation including internal phase review discipline, site quality and regulatory system.
- Interface broadly across project and global engineering teams; cross functionally with Quality/Regulatory, Service, Manufacturing, Sourcing, Project Management, and Marketing; and with various external development teams.
- Maintain open communications with company leadership and ongoing engagement of line management in project activities.
- Review and critique documentation and presentations for others; present complex technical data to large and diverse groups.
- Establish and maintain good understanding of clients, industry, and commercial markets.
- Contribute to multiple projects/demands simultaneously.
- BS Degree in Mechanical, Electrical, Biomedical Engineering or related degree.
- Minimum 10 years’ relevant post-academic experience.
- Experience with ISO (9001/13485), and regulatory standards and requirements.
- Knowledge in statistical analysis, DOE, impact assessment, root cause analysis, and risk management/FMEA.
- Experience with design for usability and electrical safety compliance.
- History of leading and conducting Design Reviews, and exposure to system modeling language.
- Experience with design verification and validations.
- Effective communication skills and ability to work cooperatively within a global, multidisciplinary team, including written and oral communication.
- Broad knowledge across mechanical, electrical and software engineering, as part of combined HW/SW systems.
- Deep knowledge in at least one discipline, including electrical, mechanical or software/automation engineering.
- GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
- Minimum of 5 years direct experience in System Engineering including designing and launching products.
- Proficient with 3D CAD modeling software.
- Capable of conducting FEA and CFD analysis.
- Master’s Degree in Engineering (Electrical, mechanical, plastics or similar field)
- Ability to manage documentation including requirements, block diagrams, specifications, cost analysis, engineering analysis, drawings, fluidic schematics, BOMs, test cases/reports, presentations, and traceability matrices.
There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting-edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world.GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.