Careers at ChromaCode

We are seeking a software developer with experience in devops platform engineering to join our growing team. You will work with software engineers to build out a cloud-based data analysis platform and associated web applications. You will be responsible for building tools to support software development and releases. You will co-ordinate with the software development team to ensure on-time delivery of production releases. We are hiring for multiple positions and the seniority/title of the final position will reflect your experience.

Who we are

We are a fast-growing early stage company, passionate about increasing the information content of molecular diagnostics data to drive better decision-making. We use state of the art methods to analyze and improve information content from widely used life science instruments. You will join a team of software developers and scientists in a well-funded, exciting startup environment. We are developing analytical, statistical, and visualization algorithms and implementing tools and software pipelines used to analyze large multidimensional biological datasets, e.g. DNA/RNA data.

What you will be responsible for

• Building and maintaining CI/CD systems
• Developing provisioning and deployment automation systems
• Coordinating and managing software releases
• Providing tools and support to other software engineers

Your ideal qualifications

You are a collaborative, strong communicator who effectively adjusts to technical and non-technical audiences. You are able to prioritize and deliver results with a high emphasis on quality, technical rigor, and attention to detail. You love working in a fast-paced environment that rewards innovation and creativity.

• 5 years development and/or operations roles, preferably a combination
• Experience managing a high-availability production environment
• Demonstrated knowledge of Kubernetes
• Demonstrated knowledge of Git
• Experience with Jenkins Pipeline development
• Working knowledge of networking concepts (routing, vlans, vpn)
• Strong proficiency with Linux and Bash scripting
• Knowledge of security best practices and experience implementing them
• Experience with AWS, primarily IAM and networking

Additional qualifications:

• Experience with other languages such as Python, Go, or C#
• Knowledge of containerization technologies (e.g. Docker)
• Knowledge of security and privacy regulatory frameworks such as ISO27001 and HIPAA

This position is based in Carlsbad, California. ChromaCode is an equal opportunities employer.

If interested, please email resume and cover letter describing your qualifications to:

hr@chromacode.com

We are seeking an experienced Senior Software Quality Engineer to join the exciting area of molecular diagnostic products. The primary focus is to use our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19, infectious disease, oncology, and other potential molecular diagnostic innovations. The qualified candidate will be responsible for sustaining Quality Assurance (QA) activities related to medical device software. The candidate will provide QA leadership to the software team in the execution of design control activities with a focus on product development, quality planning, and risk management to positively impact the safety and efficacy.

Who we are:

We are a fast-growing life sciences reagents and software company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Providing guidance regarding the effective application, compliance, and continuous improvement of procedures and practices related to software development including design controls, risk management, traceability, verification and validation.
• Defining or identifying potential compliance gaps and assess new regulations against existing or new software and computer systems.
• Reviewing and approving all project/program software deliverables (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
• Providing direction and leadership for verification and validation of non-product software, products software, software tools and components.
• Providing expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation.
• Providing expertise in ensuring software development procedures are in compliance with regulatory expectations.
• Provide quality oversight and guidance to medical device software, ensuring adherence to company procedures and ISO 13485:2016 and 21 CFR 820 requirements.
• Lead and facilitate software and process risk management related activities including facilitating software risk assessments, code reviews, and failure mode and effects analysis (FMEA) with cross functional teams.
• Lead the implementation of reviewing and revising current and newly developed software procedures, while ensuring all new software development processes and procedures are fully implemented and understood throughout the organization.
• Oversee software validation, including software tool validation activities.
• Actively participate in software product design reviews and design transfer activities for new and existing products intended to be commercially marketed or utilized in a CLIA lab environment.
• Support internal audits of the software development process and represent the QA team in quality system audits and inspections by regulatory agencies and applicable third parties.
• Support root cause investigations for software related CAPAs and complaints.
• Provide quality oversight on software updates as part of change control process.
• On-time delivery of owned QA activities (i.e., timely review of software QMS and critical program development deliverables, training, CAPA and MRB [material review board] deliverables, etc.)
• Implementation of quality key performance indicator (KPI) improvements as determined through Quality Planning

Your ideal qualifications:

• Bachelor’s degree or higher in a scientific field, (B.S. in computer science or engineering preferred)
• 4+ years related software development experience, preferably in medical device software, pharmaceutical, or in vitro diagnostic software (3+ years of experience in software and device product development preferable)
• Extensive knowledge of the different types of testing such as White/Black-box, unit, functional, regression, integration, performance, and acceptance
• Experience working with Cloud based infrastructure and systems
• Good understanding of validation. testing methodology, and software development lifecycle
• Highly motivated self-starter with strong attention to detail and proven ability to prioritize and scope work
• Excellent logic, problem-solving, and troubleshooting skills
• Excellent verbal and written communication skills
• Flexibility to handle demands of a fast-paced environment
• Adequate discipline and professionalism to work diligently within published FDA device regulatory guidelines and rigorously follow internal Standard Operating Procedures, including documentation of the testing procedures carried out for all software produced
• Knowledge of Software Security and Data Privacy standards (e.g. HIPAA, GDPR, ISO-27001) preferable
• Good leadership and communication skills for team collaboration, testing scenario feedback, and time management.
• Hands-on experience developing and implementing medical device software design control (21 CFR 820.30) related processes, preferably in a startup environment.
• Working experience and knowledge of Quality System Regulations and International Standards such as Part 11, 21 CFR 820, ISO 13485, ISO 14971, EN 62366, EN62304 and in vitro diagnostics software regulations.
• ASQ Certification as a quality engineer (e.g. CQE) preferable
• Strong technical writing skills, including the ability to write software verification and validation procedures, software development plans
• Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Experience owning CAPAs preferable
• Remote work flexibility with 25% onsite

If interested, please email resume and cover letter describing your qualifications to: People&Culture@chromacode.com.

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at People&Culture@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

We are seeking a highly motivated and detail-oriented Quality Assurance and Regulatory Affairs Specialist to join the exciting area of molecular diagnostic products. The primary focus is to use our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19, infectious disease, oncology, and other potential molecular diagnostic innovations. The qualified candidate will support the development and implementation of ongoing activities related to various Quality Assurance (QA)/Regulatory Affairs (RA) objectives with a heavy emphasis on Quality Management System (QMS) administrative and document support. The candidate will maintain/manage electronic and paper-based files.

This role is a part-time fixed-term contract until 31 Dec 2021.

Who we are:

We are a fast-growing life sciences reagents and software company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We are currently using our HDPCR™ technology to deliver some of the best diagnostic testing solutions for COVID-19.  You will join a team of highly talented people in a well-funded, exciting environment.

What you will be responsible for:

• Support Document Control and quality management system (QMS) activities at ChromaCode.
• Maintain all controlled documentation in compliance with document control procedural requirements
• Support template creation and formatting.
• Oversee document through its entire life cycle (inception to archival).
• Check and edit incoming documents and prepare for distribution.
• Create/maintain document filing and organizing systems that are both effective and efficient.
• Ensure proper organization and security of documents (paper and electronic).
• Make available, notify, and distribute documents to relevant recipients.
• Build, improve, and maintain the document control processes through daily interaction with cross-functional teams while meeting the requirements of ISO 13485 and FDA Quality Systems Regulation.
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
• Assist Regulatory Affairs (RA) in the update, enhancement, and creation of internal policies and procedures.
• Provide RA administrative assistance, facility establishment & device listing registration, organize regulatory filing, prepare regulatory meeting minutes/agenda and other regulatory administrative tasks as assigned.
• Prepare, collect, or coordinate information and prepare regulatory documentation / contracts for submission to global regulatory agencies, regional affiliates, or to commercial partners.
• On-time delivery of owned QA/RA activities (i.e., document control maintenance, periodic review reminders, RA filings, etc.)
• Implementation of any quality key performance indicator (KPI) improvements as determined through Quality Planning

Your ideal qualifications:

• Bachelor’s Degree (B.A. in a science-related subject preferred)
• Minimum of 2 years related experience required (3+ years related experience preferred)
• Experience with Document Control and regulatory filings
• Experience with electronic quality management systems software preferred
• An understanding of FDA submissions and CE-IVDD technical file documentation requirements, especially pertaining to document control preferred
• Medical device manufacturing, audit/inspection experience preferred
• Previous experience with process development and/or project management of time-critical projects required
• Must have excellent oral and written communication, presentation, and interpersonal skills
• Must provide a high level of partnership and cross-functional collaboration
• Sophisticated organizational skills, attention to detail, and the ability to balance multiple assignments is required
• Experience in a regulated environment (medical device or pharmaceutical) is preferred
• An understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to document control and quality records
• Remote work flexibility with 25% onsite

If interested, please email resume and cover letter describing your qualifications to: People&Culture@chromacode.com.

ChromaCode believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at People&Culture@chromacode.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

We are seeking a software test engineer – automation to join our Software Engineering Team. The successful candidate will work with a team of software and test engineers developing analytical, statistical, and visualization algorithms and implementing tools and software pipelines used to analyze large multidimensional biological datasets, e.g. DNA/RNA data. The software product will be used by clinical customers who require a reliable, high quality software solution to support their activities.

Who we are:

We are a fast-growing life sciences tools company, passionate about increasing the performance of molecular diagnostics instruments to drive better decision-making. We use state of the art methods to analyze and improve information content from widely used life science instruments. You will join a team of highly talented software engineers and scientists in a well-funded, exciting environment.

What you will be responsible for:

• Identify, analyze, and create detailed records of problems that appear during testing
• Track problems, resolutions, and bug fixes throughout testing
• Create detailed, comprehensive, and well-structured test plans and test cases
• Estimate, prioritize, plan and coordinate testing activities
• Develop and apply testing processes for new and existing products to meet client needs
• Work with software and test engineers to understand product architecture and features
• Build and maintain automated test infrastructures for our software product
• Design, develop and execute automation scripts using internal and open-source tools
• Participate in software design discussions to promote testability and early testing

Your ideal qualifications:

You are a collaborative, strong communicator who effectively adjusts to technical and non-technical audiences. You are able to prioritize and deliver results with a high emphasis on quality, technical rigor, and attention to detail. You love working in a fast-paced environment that rewards innovation and creativity.

• Bachelor’s Degree in Computer Science or related technical field
• 3+ year of professional web and api based software development or software testing experience.
• Programming experience in, at least, one modern programming language such as C, C#, Java
• Familiar with other languages such as Python, JavaScript
• Experience working in an Agile/Scrum development process
• Excellent problem solving and debugging skills

This position is based in Carlsbad, California. ChromaCode is an equal opportunities employer.

If interested, please email resume and cover letter describing your qualifications to:  People&Culture@chromacode.com.