About ViewRay Systems
ViewRay Systems, Inc. is a private technology company seeking to provide the global radiation therapy community with advanced medical instruments incorporating the highest level of technology possible. Our belief is that only significant technological innovation can enable society to conquer disease. Our mission is to dare to change the paradigms of medicine and solve "impossible" technical problems to enable clinicians to effect a cure to save precious human lives, mitigate pain and suffering, and enhance quality of life. Our vision is to become the world's leader in producing highly effective innovative technology to cure cancer.
ViewRay Systems designs, manufactures, and markets the MRIdian A3i radiation therapy system to treat cancer patients with the smallest radiation therapy margins available with the highest patient throughput demonstrated for the most complicated cases. The system treats by aligning the sharpest radiation therapy beam on the market to diagnostic quality magnetic resonance images (MRIs) of the patient, adapts the treatment plan to the reality of the patient, and then uses the real-time MRIs to control the beam and record real-time doses delivered to the patient.
Job Description
ViewRay Systems, Inc. is looking for a Sustaining Quality Engineer that shares our passion for conquering cancer and help us support radiation therapy systems worldwide. The ideal candidate shares enthusiasm for engaging in the best business practices while improving cancer therapy. You will be assisting with the investigation and resolution of quality-related supplier, production, manufacturing, and customer-reported quality issues.
Responsibilities include the following and other duties may be assigned
- Respond to day-to-day hardware and software design, production, and customer quality issues including resolution of process errors, non-conforming parts, and design problems.
- Support updates to the device master record and bill of materials.
- Provide input and oversight for in-house production, supplier controls, and change control including quality documentation development, review, and approval.
- Apply knowledge of quality engineering principles including design transfer, statistics, and process & systems validation to positively influence manufacturing.
- Ensure product changes are implemented in accordance with applicable industry standards, regulatory requirements, and customer requirements.
- Collaborate with R&D, Service and Operations to ensure quality standards are in place to rapidly and permanently resolve quality problems as they arise.
- Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
- Continuously look for opportunities to improve product quality and processes related to quality. Proactively create and drive teams to drive improvements.
- Audit and approve installation, service, supplier, manufacturing, quality, engineering, and verification documents for conformance to business practices and departmental procedures.
Education, Experience, Skills
- Bachelor's degree in a related engineering field (ME, EE, IE,CS) or equivalent.
- 3-5 years of successful experience in a product manufacturing and supplier-related product quality assurance positions.
- Experience of quality activities, proficient analysis of technical documents such as blueprints, material specification sheets, etc. related to supplier quality, manufacturing and installation.
- Knowledge and experience with FDA & ISO13485 Quality System regulations including those related to purchasing, production & process, and Design Controls.
- Process improvement capability and experience with Lean and Six Sigma tools, DMAIC problem solving, DFMEA, DOE, SPC, etc.
- Hands on experience and thorough knowledge of UL and IEC requirements for medical devices.
Personal Interactions
- Ability to communicate effectively, both orally and in writing, at a variety of technical levels.
- Ability to work effectively as part of the diverse team including physicists, scientists, and engineers in a fast-paced environment and with multiple projects.
- Able to travel up to 10% & lift 50 lbs.
Job Type: Full-time
Pay: commensurate with experience.
Ability to Relocate: Cleveland, OH 44128: Relocate before starting work (Required)
Work Location: In person in Cleveland, OH: Relocate before starting work (Required)
Benefits:
- Health, dental, and vision insurance
- Paid time off and flexible schedule
- Office stocked with snacks, drinks, and occasional catered meals
ViewRay Systems, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, creed, national origin, gender, age, sexual orientation, status as a protected disabled or Vietnam Era Veteran, disability, or any other legally protected status.