Role Summary :
The Project Engineer, R&D Custom Hardware position, in the GE Healthcare Life Sciences business will focus to execute custom projects and engineering services for single use bioreactor hardware systems (XDR).
This position requires the application of design, engineering, product testing and good documentation practices. You will executes technical tasks on multiple projects as assigned, and contribute to engineering efforts in resolving process and / or quality issues.
Essential Responsibilities :
Executes the design, analysis, or evaluation of assigned tasks using sound engineering principles and adhering to business standards, practices, procedures, and product / program requirements.
Creates and maintains detail and assembly drawings, component specifications and associated Bills Of Materials (BOMs).
Generates and maintains project-specific product documentation such as P&ID, general assembly drawing, general system specifications, test protocols and assembly instructions.
Participates in and prepares materials for technical design review meetings.
Releases components and product documentation through ECR / ECO process.
Collaborates with other members of the project team in providing design engineering and project documents for transfer to manufacturing.
Assists with verifying product performance against design inputs and user requirements.
Assists with resolving design, documentation and / or quality issues during system’s build and testing phase.
Supports customer case management tasks for custom products in the field as needed.
Ensures that project and product documentation is in conformance with Regulatory, EHS, and GEHC QMS requirements.
Awareness of GMP and governmental regulations related to process equipment used in bioprocessing.
Quality Specific Goals :
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type / position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Support compliance / closure of Regulatory and Quality requirements before completing Design Outputs / Program Deliverables.
Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives.
Qualifications / Requirements :
Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Industrial Engineering, or related field.
Minimum of 3 years hands-on design and implementation experience in either : bio-processing, process equipment, biotechnology, medical device development or related project engineering field.
Broad exposure to multiple engineering disciplines (Mechanical, Electrical, Software, etc.)
Ability to read and interpret engineering drawings, technical procedures and specifications.
Strong communication and technical writing skills for working with global manufacturing, commercial and customer support team.
Desired Characteristics :
Master’s degree in Engineering / Science and 3-to-5 years relevant work experience
Self-starter, energizing, results oriented and able to multi-task
Excellent teamwork, coordination and communication skills
Ability to meet aggressive reliability, performance, cost, serviceability, and delivery targets
Quality and Compliance documentation focused
Experience with regulated industries (GMP, GAMP,FDA)
Project management experience