Current Job Openings (email resume to: firstname.lastname@example.org)
TITLE: Scientist III
DEPARTMENT: Research and Development
REPORTS TO: Staff Scientist – Research Group Manager
A Senior Scientist responsible for the research and development of the TangenDx molecular diagnostic platform, including generating data in support of product development and applications. The position involves hands-on laboratory work and the individual will be responsible for execution of experiments related to assay development and workflow optimization. This individual will work with scientists and engineers in Research and Development, as well as external customers and research collaborators.
- Independently design and execute complex, well-controlled experiments.
- Be accountable for development of sample preparation, isothermal amplification assay, and assay disk preparation workflows.
- Perform critical data analysis and optimize laboratory protocols.
- Work with Engineering leaders to develop and test new designs
- Strong quantitative reasoning skills; versant in Microsoft excel, Matlab and some programing language skills a plus.
- Maintain detailed and reliable laboratory records. Write reports and present results, project and technology assessments.
- Knowledge of microbiology, molecular biology, microfluidics, and biostatistics;
- Documentation compliance with a high level of attention to detail;
- Must demonstrate excellent computer skills.
- Strong organizational skills and ability to prioritize tasks;
- Ability to work both independently and as part of a team; ability to motivate self and others;
- Excellent oral and written communication skills.
Experience and Education
- PhD. degree in the field of engineering, bio-engineering, microbiology, molecular biology, biochemistry or related fields;
- A minimum of 5 years post-baccalaureate laboratory experience in a research and/or industry environment;
- Experience with nucleic acid extraction/purification/amplification, and molecular assay development including Design for Manufacturing engineering based projects.
TITLE: Lead Engineer – Electrical
REPORTS TO: Director of Engineering
This position will perform all aspects of Software/Firmware and embedded system hardware design from the initial feasibility stage to manufacturing release for next generation in vitro diagnostic medical instrumentation. This position will be responsible for development efforts including all planning, scheduling, and documentation required. Architect, code, implement, and test the design. Design new PCBs using schematic capture and PCB layout tools. Design firmware and/or software for target PCBs where applicable, and verify designs using various test equipment and software test methods.
- Component-level design and layout of PC boards to ensure adherence to electrical standards as it relates to safety and EMC;
- Interpret and apply agency standards;
- Develop design control documentation to support new product development, troubleshoot equipment failures, write change notices, develop project requirements
- Execution of mechanical and electrical testing to support the selection, design verification, commercialization and marketing of various designs.
- Identify, develop, implement, qualify and validate new testing methods (and equipment if required) to meet capability and capacity needs of the project.
- Develop software/firmware to execute product requirements following Agile methodology.
- Develop and document test procedures for firmware/software unit, integration and system testing.
- Actively leads and coordinates the design, development and review of embedded systems while driving ongoing process improvement across the engineering function with minimum supervision;
- Strict adherence to design controls in a regulated environment such as, ISO 13485, FDA GMP, and other relevant compliant quality management systems across the medical device spectrum;
- Strong organizational skills with the ability to prioritize tasks, self-driven and independent in leading the engineering processes
- Develop software/firmware following software lifecycle management process such as ISO-62304.
Typical Tools, Technologies
- Interfaces: I2C, SPI, USB Full Speed and High Speed, 802.11, RS-232, Bluetooth (standard and BLE), Ethernet
- Technologies: Embedded Microcontrollers (e.g., ARM Cortex M4 Microcontrollers such as the STM32F4 series), System on Chip (SoC), Real Time Operating System (RTOS)
- Tools: C, C++ (Std 11), Object Oriented Design, Design Patterns, Configuration Management (CM), Modern IDE’s (Such as Keil and IAR), unit testing and mocking frameworks.
- Proficient in standard design and development tools such as Confluence, Jira, Bitbucket, Microsoft Office, OrCAD Capture, Allegro PCB Editor, Solid Works and the Agile approach to Software development life cycle.
- Software/Firmware test methods such as unit testing, black box/white box testing, integration testing, and regression testing.
- Real Time or Safety Critical Systems
Experience and Education
- Experience with analog, digital and programmable devices.
- Minimum 7 years relevant experience in the design and development of electronic PCBA systems in a medical device setting.
- Working knowledge of electronic design principles and medical device design control methods.
- Working knowledge of UL, IEC, and CE Requirements.
- Experience with high-speed digital hardware design.
- S. or M.S. in electrical or computer science engineering.
TITLE: Process Development Automation Engineer II
REPORTS TO: VP Operations
The Process Development Automation Engineer will be well-versed in the latest automation technologies, have hands on experience programming liquid reagent dispensing handlers and be willing to work in a fast-paced environment. The ideal candidate understands platform based liquid reagent technology and general laboratory automation and will be responsible for helping to identify and support the implementation of automated clinical IVD assay Kit manufacturing solutions for existing and future platforms.
- Applying mechanical theory, mechanical testing procedures and related knowledge to layout, build, test, troubleshoot, repair and modify developmental and production equipment.
- Creating detailed statements of work and technical specifications for procuring automated solutions, source selection
- Identifying and working with automation suppliers overseeing design, programing, fabrication and integration, supporting implementation of equipment into manufacturing and providing sustaining support and troubleshooting during production.
- Collaborates with the design engineers during preliminary and detail design phases to assure designs are producible with proposed automated solutions and can be fabricated to meet cost and schedule targets.
- Performs process analyses (sequence and content of assembly steps, time studies, material flow analysis) and develops to-be assembly concepts.
- Improves process capability and production volume while maintaining and improving quality standards.
- Programs software to configure and/or make modifications to automated systems and process control systems, which will include maintaining a backup library of robotic, PLC and other instrumentation software.
- Estimates times, resource requirements, and related material and labor cost to provide information for projects and other decisions related to the manufacturing process.
- Design FMA from the early stages of the product development
- Process analysis, FMEA, Cost analysis
- Design of fixtures, testing devices and tools for automation
- Manages the build of pilot run and provide proof of, or optimize, process ability
- Decision Quality – Making well-informed and timely decisions that keep the organization moving forward
- Drives Results – Balancing competing priorities without comprising quality. Consistently achieving results with a sense of urgency.
- Communicates Effectively – Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences
- Manages Ambiguity – Resourceful and resilient; operates effectively, even when things are not certain or the way forward is not clear
- Instills Trust – Gaining the confidence and trust of others through honesty, integrity, and authenticity
- Ensures Accountability – Holding self and others accountable to meet commitments
- Cultivates Innovation – Creating new and better ways for the organization to be successful
Experience and Education:
- Bachelor’s Degree (B.S.) in Engineering from a four-year college or university.
- Three to five years of directly related Manufacturing Engineer experience in automation
- Have experience with product commercialization in the realms of medical device or biotechnology
- Must be familiar with ISO 13485, Lean Manufacturing, and have good knowledge of Solidworks and LabView
- Experience in automation and/or injection molding and/or Liquid dispensing operations
- Strong technical ability