Singulex is an immunodiagnostics company at the forefront of Single Molecule Counting technology, a novel immunoassay technology recognized for unprecedented ultra-sensitivity in the precision measurement of biomarkers. Singulex is the developer of the Singulex Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. With up to 1000 times more sensitivity than existing technologies, Single Molecule Counting reveals the presence or absence of disease more clearly and definitively than was possible before. In 2017, Singulex filed a 510(k) pre-market notification submission with the U.S. Food and Drug Administration. The Singulex Clarity system and Singulex Clarity assay have the CE mark and are commercially available in Europe. Additional assays to detect and rule out infectious and inflammatory diseases are in development. Singulex is also developing a point-of-care platform and exploring applications beyond the clinical setting. For more information, please visit singulex.comOpens a New Window. or singulexclarity.eu.
Singulex Corporation develops cutting edge, optically-based, ultra-high sensitivity protein detection systems for clinical diagnostics applications. Singulex products employ a wide range of subsystems including lasers, scanning confocal optical systems, robotic plate handlers, liquid sample handlers, incubators, washers, sophisticated mathematical algorithms and state of the art control and analysis software. Singulex is looking for a talented, highly motivated individual to work in the Hardware Development Group to expand Singulex product line and develop new intellectual property in state of the art diagnostics instruments.
- Hands-on instrumentation design and development. Ideally suited for senior level engineer who has the skills to combine analytical and empirical methods for instrumentation design and enjoys immersion in the details of designing, building, testing, and debugging complex state-of-the-art optical and fluidic-based instruments.
- Develop analytical models in Matlab, C++, Visual Basic or other programming environment to simulate, physical behavior on of instrument to understand factors influencing sensitivity, precision and cost. Use modeling to direct, optimize and refine design approaches for diagnostic instruments.
- Develop electronics instrumentation architecture for real time instrument control, including motion control, illumination, low noise signal collection, data processing, user interface devices, and interface to laboratory information systems.
- Conceive, design, develop and test custom analog and digital circuits/systems for stepper motor control, closed loop DC servo systems, high speed DC brushless motors, high output LED based illumination, LASER based illumination, single photon counting APD’s and PMTs, liquid level sensing, displacement encoders, USB cameras and power distribution.
- Apply strong analytical skills with sound decision making for complex multidisciplinary problem solving.
- Perform design and schematic capture, PC board layout using Altium or Orcad.
- Identify, select, work with and manage 3rd party developers and suppliers
- Develop production techniques, procedures and test protocols to support transition of designs to production.
- Support, develop, and implement modifications to existing products to solve performance, regulatory compliance, reliability, and production or field service issues.
- Develop detailed bills of materials, schematics, source control documents etc.
- Develop ISO and FDA Design Controls documentation, conduct Design Reviews and follow Singulex Product Develop Operation Procedures
- Support Singulex current product line and enhancements to ensure customer satisfaction, regulatory compliance and profitability
- Extend Singulex’ proprietary techniques and intellectual property into new products and markets.
- Develop new intellectual property for high sensitivity analyte detection and quantitation in diagnostics, screening and other applications.
- Take direction from Singulex management and implement solutions.
- Conduct business activities in a highly professional manner to build respect among team members and serve as role model and mentor to younger staff members.
- Make yourself and the Hardware Development group a valuable resource for the broader company.
- Use technical expertise to help assess and create new business opportunities.
- Involved in all electrical engineering aspects of Singulex’ instrumentation designs.
- Involved in all electrical engineering aspects related to production of Singulex’ products.
- Involved in all electrical engineering aspects related to field support of Singulex’ products.
- On-site expert/resource for electrical engineering activities. Work with Singulex Fellow and technology founder on a variety of projects to expand Company capabilities.
- Work with internal Assay, Marketing, Sales, and Business development teams as needed to understand new product requirements.
- Work with internal Project Management, Regulatory, and Quality teams to ensure product documentation compliance for ISO, FDA Design Controls environment.
- BS, MS and or PhD in Engineering, Physics or related field.
- Minimum of 10 years of post-degree, professional experience developing instrumentation
- 5+ years of experience in development optical instrumentation
- 5+ years of experience in development of Diagnostics and or Life Sciences
Skills and Competencies: (Ideal list included below)
- Knowledge and experience with implementation of micro controllers.
- Knowledge and experience with implementation of Single Board Computers.
- Knowledge and experience with Altium or Orcad.
- Knowledge and experience with programming in C++.
- Knowledge and experience with Linux operating system for instrument control and or Real Time Operating Systems.
- Knowledge and experience with working with FPGA’s and programming in VHDL (or similar hardware description languages).
- Knowledge and experience with controlling and using diode lasers.
- Knowledge and experience with controlling and using high powered LEDs.
- Knowledge and experience with using and developing circuits for low noise signal capture and photon counting using Photo Multiplier Tubes and Avalanche Photo Diodes
- Knowledge and experience with USB and Web cameras for low cost image capture and processing.
- Knowledge and experience using stepper motors, DC brushless motors, linear motors, servo motors, solenoids.
- Knowledge and experience in Bluetooth, WiFi, Ethernet, USB robust communication and data transfer techniques.
- Knowledge and experience with using smart phones, tablets, touch screens or other low cost ubiquitous devices for product user interface.
- Knowledge and experience with design and testing for Regulatory Compliance Directives for EMC/EMI, FCC, FDA/CDRH, CE, CSA, TUV and NRTL.
- Knowledge and experience with ISO and FDA Design Controls for Hardware development of medical devices.
- Knowledge and proficiency with rapid turn prototype PC board fabrication and assembly including soldering surface mount devices etc.
- Demonstrated ability to develop creative approaches and practical solutions to complex technical problems.
- Excellent cross-functional communication, writing, presentation, planning, collaboration, and leadership skills.
Singulex provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Singulex complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leave of absence, compensation, and training. Singulex expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Singulex's employees to perform their job duties may result in discipline up to and including discharge.