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 real-time 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 of instrument to understand factors influencing sensitivity, precision and cost. Use modeling to direct, optimize and refine design approaches for diagnostic instruments.
- Develop precision mechanical systems for motion, illumination, signal collection, sample transport, fluidic reagents transport, assay reaction chambers, air filtration, cooling, power distribution and agency safety requirements.
- Conceive, define, design, prototype and test product and subassembly approaches
- Design, draw and or specify subassemblies and individual components.
- Fabricate and or modify individual parts in on-site prototype machine shop for the purpose of rapid prototype build and test.
- Identify, select, work with and manage 3rd party developers and suppliers
- Develop production techniques, procedures and alignment tooling and 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, drawings, 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.
- Input into all mechanical engineering aspects of Singulex’ precision instrumentation designs.
- Input into all mechanical engineering aspects related to production of Singulex’ products.
- Input into all mechanical engineering aspects related to field support of Singulex’ products.
- Work with internal Assay, Marketing, Sales, Business development teams to understand product requirements.
- Work with third party developers/suppliers for Singulex instrumentation product design and support.
- Work with internal Project Management, Regulatory, 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 mechanical design of precision XY stages.
- Knowledge and experience with mechanical design of precision focus and rotary stages.
- Knowledge and experience with design of microfluidic devices.
- Knowledge and experience with mechanical design of air filtration and instrument cooling systems.
- Knowledge and experience with mechanical design of vibration isolation systems.
- Knowledge and experience using stepper motors, DC brushless motors, linear motors, servo motors, and solenoids.
- Knowledge and experience with mechanical design of precision fluidic pumps and fluidic valves.
- Knowledge and experience with opto/mechanical design of mounts for mirrors, beam splitters, lenses, objectives, diffraction gratings, light pipes, fiber optics, cameras, photomultiplier tubes, and APDs.
- Knowledge and experience with mechanical design of illumination sources including LASERs and LEDs.
- Knowledge and experience with die casting, sand casting, thermal molding and injection molding.
- Knowledge and experience with bonding techniques for components in precision optical instruments.
- Knowledge and experience with tooling for alignment and production of optically-based instrumentation.
- Knowledge and experience with mechanical system performance, reliability and thermal test techniques and practices for optically-based instrumentation.
- Knowledge and experience with ISO and FDA Design Controls for Hardware development of medical devices.
- Knowledge of machining practices and tolerances.
- Demonstrated high level of proficiency with Solidworks.
- 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.