The R&D Technician will be responsible for supporting the R&D, Operations, & Quality departments with a variety of activities and projects to meet the company’s objectives and key initiatives. This creative role reports to the R&D Manager for direction and offers independence along with team collaboration in a fast-paced environment.

Location: Sunnyvale, CA (This is a day shift position, on site Monday-Friday.)

Responsibilities:

Research and Development:

• Management of R&D laboratory equipment, calibration, and supplies
• Fabrication and assembly of prototypes to support new product development
• Work with engineers to develop laboratory test methods, fixtures, and protocols
• Execution of laboratory testing and documentation of results
• Identification and Implementation of process improvement and optimization
• Operation and maintenance of 3D printers (Prusa, Markforged, & Bambu)

Operations:

• Preparation and shipping of product training materials to support field training events
• Handling of returned goods
• Inspection, testing, and servicing (including upgrading) of capital equipment
• Device History Record (DHR) tracking
• General site related FedEx shipping and receiving support
• Label printing

Quality:

• Receipt, cleaning, & processing of returned product
• Investigation and root cause analysis of returned product
• Documentation of failure modes of returned product.

Essential Functions:

• Organize lab supplies and materials and develop associated processes for ensuring visibility and traceability of current supply levels; develop systems for replenishment of supplies and materials as needed
• Maintain Lab equipment, perform preventative maintenance, and coordinate calibration activities
• Fabricate and assemble prototypes per design specifications, prints and/or engineering direction to support product and process development and testing
• Document materials and processes of prototypes and devices made for testing
• Troubleshoot and suggest creative solutions to process and/or design issues
• Assist with developing manufacturing and test processes and fixtures
• Conduct laboratory testing on prototypes, developmental devices, and commercial product with excellent attention to detail and document results
• Maintain an accurate lab notebook and record of assignments and results including documentation concerning materials, parts used, concepts, designs, drawings, and processes according to good documentation practices
• Update engineers of work status or problems with recommendations for improvement or correction
• Oversee and operate 3D printer farm including starting daily print jobs, performing maintenance, and managing consumable inventory.
• Process commercial shipments to customers per standard operating procedures, including creation of shipping paperwork and documentation of shipping logs
• Contact field sales personnel and customer account representatives to coordinate product shipment logistics
• Maintain and organize local supply status of commercial product to support urgent and rush orders to customers
• Prepare product samples for use in product demos and field training events
• Maintain and organize local supply status of training materials to support field training events; trigger replenishment per component lead time and planned demand
• Receive, process and document commercial product returned goods
• Clean and disinfect returned goods in preparation for technical analysis and troubleshooting in support of product complaint investigations
• Collaborate with engineers to provide support in the resolution and documentation of product complaint investigations
• Service, upgrade and maintain capital equipment returns in support of replenishment to the field for the rental fleet program
• Maintain a clean, safe, and well-organized work area
• Support company goals and objectives, policies and procedures, QA, and FDA regulations

Experience:

Required:

• Minimum 4 years of experience working in a technical support role, using equipment and processes to develop, build, test and service medical devices (higher education enrollment, certification and/or degree years may be substituted for work experience)
• Experience with mechanical device fabrication, equipment, and assembly
• Experience with mechanical test equipment similar to Mark-10, Instron, & MTS test frames
• Experience with general laboratory tools and instrumentation (microscope, calipers, digital multimeter)

Desired:

• Experience with design verification testing and test methods
• Experience with root cause analysis and troubleshooting of product issues from the field
• Experience with metals, including Nitinol, and polymers
• Experience with 3D printers (FDM)
• Experience with creating word processing templates and building spreadsheets using functions (MS Word and Excel), as well as the ability to understand engineering drawings and documentation

Skills/Aptitudes:

• Excellent written and oral communications skills
• Capacity to work in a high paced, changing environment, and interface effectively with others
• High proficiency using MS Excel, MS Word and MS PowerPoint
• Outstanding attention to detail and understanding of good documentation practices
• Must be able to work on problems requiring the exercise of autonomy, judgment, and expertise
• Ability to lift up to 30 lbs on occasion

Education/Training:

• 2-year associate degree preferred, but not required