Sr./Principal/Staff Design Engineer (Medical Device, Microfluidics)

SNAPSHOT 

Our client is a healthcare company committed to improving global health outcomes by detecting diseases in their earliest stages! Specifically, the company is in the process of developing diagnostic solutions that will lead to better ways to screen, diagnose, and manage high burden conditions. In this role, the Senior Design Engineer, Consumables will lead the design, development, and testing of consumables that integrate our novel core technology and automate assay workflows for the isolation and quantification of key biomarkers in a multitude of application spaces! The role will play a vital role as a member of a dynamic team of engineers and scientists at the interface of microelectronics and molecular biology. Our client is offering top market compensation, excellent benefits, and progressive career opportunities!

Immediate direct hire opportunity for a Senior Design Engineer (Microfluidics) in San Diego who possesses:

• BS/MS/Ph.D. in Mechanical Engineering, Bioengineering, Biomechanical Engineering, Materials Science, or similar academic background

• 5+ years of design engineering experience developing microfluidic devices or similar in biotech, medical device, or similar setting

• Experience with the design and fabrication of microfluidic devices, particularly bonding and assembly processes

• Data-driven, proficient with the design of experiments (DOE), statistical analysis, statistical process control (SPC), failure modes and effects analysis (FMEA), and structured problem solving

• Technology transfer experience, particularly transferring designs and processes from R&D to production facilities at suppliers

• R&D experience developing consumables for life sciences

• An understanding of microfluidic physical phenomena

• Experience working in risk management (ISO 14971)

• Experience working under design controls (21 CFR 820)

• Experience working under a quality management system (ISO 13485 or similar)

• Results-driven, self-motivated, self-starter, motivated by difficult technical challenges, able to work independently and in teams

• Demonstrates strong technical ability and creativity at a fundamental level

RESPONSIBILITIES INCLUDE:

• Drive the design of new diagnostic consumables and develop robust fabrication and assembly processes to meet product requirements/design inputs in collaboration with internal teams

• Serve as the technical lead for the design and performance of all components used in the fabrication of diagnostic consumables

• Lead R&D efforts to improve the manufacturability, yield, and reliability of BLI consumables

• Collaborate with the manufacturing team on cost reduction and capacity expansion efforts as we scale

• Work closely with suppliers to test new fabrication and assembly processes and to scale those processes to meet specifications

• Become the resident expert for all processes used to design and fabricate diagnostic consumables such as:

• Polymer injection molding

• Extruded polymer laser cutting

• Adhesive laser and die-cutting

• Laser welding

• Ultrasonic welding

• UV adhesive dispensing and curing

• 2D and 3D computer-aided design (CAD) and modeling

• Design for manufacturability (DFM) and economic viability

• Solicit, analyze, and document engineering requirements/design inputs

• Maintain and updates requirements and design documentation throughout the entire system life cycle

• Aid in biosensor design and development

For immediate consideration, please email your resume to admin@snapstaffing.com