Senior Electrical Engineer
Vertex Pharmaceuticals
- Providence, RI
- Permanent
- Full-time
- Technical Project Management, including the development of schedules, resource requirements, and communication dashboards.
- Co-development of industrial automation used for production and assembly of cell encapsulation devices.
- Support optimization and improvement in equipment/systems/processes.
- Control System Design of Assembled product machinery; design for manufacturability; design for safety.
- System design, including technology selection, vendor selection, URS, FRS, design documents, and cross-functional technical coordination.
- Identify and manage vendors to assist in industrial automation solutions. Experience working with panel build vendors and industrial machinery integrators.
- Perform Failure Mode Analysis as input to design; creates failsafe designs for critical processes.
- Robotic programming, including, but not limited to SCARA robots.
- PLC programming utilizing Allen Bradley and Siemens.
- Integrate machine vision into industrial applications.
- Design and implement Engineering Safeguards including, but not limited to guarding, light curtains, E-Stops, and Safety Circuits.
- Design and Document Safety Circuit Performance Levels according to ISO 13849-1:2023.
- Follow relevant standards, such as NFPA 70 and 79.
- Electrical Power Panel Design, including Short Circuit Current Rating single line diagrams.
- Equipment debug, including the use of oscilloscopes, PLC trending, and high speed video.
- Establishes equipment documentation, including parts lists, electrical drawings, and pneumatic drawings. Provides engineering change documentation as appropriate.
- Executes and documents equipment commissioning activities including Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). Supports equipment qualification and process validation activities (IQ, OQ, PQ).
- Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
- Statistically characterizes equipment performance and implements designs to ensure repeatability and consistency.
- Create or manage the creation of schematics in AutoCAD.
- Provide hands-on troubleshooting, equipment, and manufacturing assistance in support of a rapid development cycle and manufacturing sustainability.
- Execute assigned duties on time and within budget; proactively telegraph delays and other issues to relevant stakeholders.
- Comply with all regulatory, corporate, and Quality System policies.
- Support Deviation Management, CAPA, and Change Control activities, as required.
- Performs other duties as assigned.
- BS or MS in engineering or another relevant discipline.
- 8+ years of experience (5+ years with Masters) working within an automation development environment (medical device, cGxP preferred). Experience with device-biologic combination products is highly desirable.
- Experience working with a variety of automation hardware, including but not limited to, cam systems, linkages, index and dwell machines, servo systems, cartesian robots, SCARA robots, and end of arm tooling.
- Experience qualifying and validating manufacturing equipment and processes is required. Knowledge and experience in utilizing risk-based approaches to process development and validation are highly advantageous.
- Ability to coach and train less experienced engineers.
- Understanding of cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21CFR820 is a plus. Knowledge of global cGMP requirements governing device or combination products.
- Familiarity working with and troubleshooting industrial automation (Siemens PLC/HMI, Epson, Universal Robotics, PC-based systems, process instrumentation). PackML programming experience preferred.
- A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.
- Hands-on approach to problem solving, risk identification and resolution. Six-sigma Green Belt / DMAIC problem solving experience preferred.
- Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
- Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management.
- Must demonstrate strong interpersonal, presentation, and teamwork skills.