Careers

Engineering Opportunities

Senior Software Engineer

Summary

Seraph Biosciences is seeking a Senior Software Engineer with cloud architecture (AWS), database (SQL), and embedded medical device (C++/SQL/QT) experience. The successful applicant will work in collaboration with a primary software development partner, senior software engineer / researcher, and biomedical lab team. Primary responsibility will be to develop and implement overall cloud architecture, related API’s, and a secure database strategy.

The Senior Software Engineer will have excellent problem-solving skills and a working knowledge of embedded systems. The core application is Windows-based embedded software built with C++, QT, and SQL. Proprietary algorithms have been developed using Python. Long term plan is to port existing application over to Linux for HIPPA compliant FDA clinical trial.

Responsibilities

The selected candidate will have the following responsibilities.

  • Report directly to Director of Engineering and collaborate directly w/CEO, Senior Software Engineer and software development partner
  • Core tasks will include requirements definition, AWS architecture design/development, secure database strategy/implementation, and related coding
  • Conduct code reviews, unit testing, debugging, and software/hardware integration.
  • Develop tools and applications by producing clean, efficient code
  • Collaborate with senior software engineer and software development partner to improve core application
  • Support quality checks such as milestone reviews and quality assessments
  • Document development phases and monitor systems

Qualifications

  • BS or MS in Computer Science, Electrical Engineering or a related degree
  • Strong development/implementation experience w/ AWS, related API’s, and SQL
  • Strong development/implementation experience with HIPAA compliant network security
  • Strong development/implementation experience using Agile development life cycle
  • Strong development/implementation experience w/ Jira and Git
  • Familiarity w/ QT, C++, and  Python
  • Familiarity with firmware, device drivers, and multiple threads
  • Ability to work independently and efficiently in a fast-paced environment

Preferred

  • Experience developing and debugging kernel drivers for Windows and embedded Linux
  • Experience with ARM-based processors
  • Experience w/ embedded Linux applications , file-systems, boot process, or driver architecture
  • Experience with Static Code Analysis
  • Experience developing applications or drivers for USB host-side or client-side
  • Experience with the data link layer and device drivers


Regulatory & Quality Assurance Opportunities

Quality Engineer

Summary

Seraph Biosciences is seeking a Quality Engineer to support its FDA 510(k) de novo application. The ideal candidate will actively participate in the company’s product development cycle by reviewing mechanical, electrical, and software project documentation, participate in product risk assessments, and work closely with the Product Development team to develop appropriate verification and validation testing requirements. The quality engineer will also fashion solutions to a wide range of difficult regulatory challenges and work independently to create protocols that are imaginative, thorough, practicable, and consistent with organizational objectives.

Responsibilities

  • Report directly to the Manager of RA/QA and collaborate with the Director of Engineering and operations team on a regular basis
  • Assess overall product risk by facilitating the development of risk management tools including risk management reporting and failure mode and effects analyses (FMEAs)
  • Collect, analyze and interpret statistical data
  • Perform analyses and provide reports to management as required
  • Prepare procedures, protocols and test reports in support of establishing a quality system
  • Monitor supplier performance and initiate corrective actions (CAPA) as required by the management team
  • Create and monitor supplier quality agreements
  • Work with contract manufacturers to ensure compliance with QSR and GMP’s
  • Track timelines and facilitate required Quality Engineering deliverables
  • Assist with projects and assure creation and consistent implementation of best practice quality engineering tools
  • Provide support to other quality groups both internal and external to Seraph Biosciences, Inc. to ensure efficient completion of project requirements
  • Identify and implement software process metrics for the software product development life cycle
  • Develop, analyze, and monitor metrics which pertain to software defects uncovered during development, testing, and post-release
  • Travel may be required up to 20%

Qualifications

  • Bachelor’s degree in engineering, math, physical science, or equivalent field
  • Minimum experience of 2+ years in a regulated industry
  • Strong development/implementation experience of the Microsoft Office suite
  • Strong command of the English language and excellent written communication skills
  • Exceptional attention to detail
  • Familiarity w/ QT, C++, and  Python
  • Familiarity with firmware, device drivers, and multiple threads
  • Ability to work independently and efficiently in a fast-paced environment
  • Ability to be self-motivated and work independently with minimal supervision
  • Have the capacity to collaborate on a daily basis with a wide variety of engineers, physicists, programmers, lab technicians, and management teams
  • Strong analysis and problem-solving skills

Preferred

  • Demonstrated statistical knowledge and Minitab experience
  • Demonstrated ability to document test data, analyze test results utilizing statistics, write clear and concise lab reports, and make recommendations to evaluate product
  • Have a proven track record of experience in writing procedures, workflows, and Instructions for Use documents
  • Have the ability to assist in the development and maintenance of quality programs, systems, processes, and procedures
  • Provide guidance on the principles of electrical engineering and IEC standards as they relate to the new product development activities of electromechanical medical devices
  • Provide guidance on Human Factors Engineering as it relates to the product design process
  • Familiarity with IEC 62304, ISO 13485, QSR, ISO 61010
  • Familiarity with Jira and the Agile software development process

EEO & Employment Eligibility

Seraph Biosciences, Inc. is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Seraph Biosciences, Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Company

Seraph Biosciences was created specifically to commercialize Seraspec®, a Raman spectroscopy-based platform technology for real time pathogen detection and identification at the point of care. Seraspec® represents a paradigm shift away from existing methods for identification of dangerous bacterial, viral, fungal and parasitic infections. Our patent pending technology and method of detection effectively eliminates the need for costly and time-consuming laboratory-based methods of specimen collection, processing and pathogen identification

Please feel free to send completed applications (resume, cover letter & references) to our company email or via mail at Seraph Biosciences, Inc., 19 Clifford Street, Detroit, Michigan 48226.

Seraph Biosciences, Inc. is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

 

 

 

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