Description

The Company 

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health. 

Job Purpose

You will be part of a dynamic organization of engineers, scientists and quality specialists developing a novel intradermal biosensor technology. It is an influential role impacting quality and product development, using knowledge of software quality assurance, design control, risk management, as well as software and firmware design and development. You will establish or improve the software quality assurance processes, standard operation procedures, organizational frameworks, and technical infrastructures. You will ensure that Biolinq’s medical device software products meet quality standards and are complying of FDA and EU regulations and international quality system standards. You will ensure that the GxP software are in validated state. You will build and manage the software quality team.

You will verify and validate software products and non-product software using extensive knowledge of software testing, design control, and risk management. You will provide input to the software quality assurance processes, standard operation procedures, and technical infrastructures. You will contribute to achieve and maintain compliance with regulatory expectations and international quality system standards.

Duties and Responsibilities

• Update and maintain all Software SOPs, including product, non-product, and cybersecurity. 
• Develop and maintain software verification and validation plans, test plans, test cases, test sets, test reports, traceability matrices, and verification and validation reports
• Conduct software inspection, testing, verification, and validation of firmware, mobile apps, web apps, cloud services, and APIs
• Work closely with the software development team to identify, track, and correct defects
• Engage in quality activities throughout the life cycle of product development
• Design, implement, and maintain manual and automated test framework and infrastructure
• Enable software developers to deliver quality software through Software Development Life Cycle (SDLC) processes and internal audits
• Ensure design, project, and process control documentation are compliant with US and OUS regulations
• Participate in software design review and software change request review
• Apply risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure modes and effects analysis) for product design and process design
• Perform root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions
• Provide qualitative and quantitative metrics to improve software product quality
• Prepare, support, and ensure the readiness for internal and external audits and inspections
• Plan and execute non-product GxP software assessment, qualification, and validation

Requirements

 Qualifications

• BS or MS Degree in Computer Engineering, Computer Science, Electrical Engineering, or equivalent field
• 5 years’ experience in software quality assurance in regulated medical device industry (i.e., 510(k), PMA)
• Solid knowledge of wireless data transmission protocols, particularly BluetoothTM Low Energy®
• Proven record of managing software development design control (21 CFR 820.30, ISO 13485), software verification and validation (FDA’s General Principles of Software Validations), software development life cycle (IEC 62304), and regulatory submission documentation
• Extensive experience with ISO 14971 Medical devices — Application of risk management to medical devices
• Extensive experience with 21 CFR Part 11
• Excellent ability to interface with cross-functional department leaders and work in a fast-paced, multi-disciplinary environment
• Experience in Quality Assurance with a focus on software testing, design control of software development, software verification and validation.
• Knowledge of applied statistics and experience with statistical software applications
• Experience with design, project, and process control documentation reviews for compliance
• Experience with reviewing software design and change control
• Experience with software configuration management
• Experience in supporting an agile and/or DevOps software development environment
• First-hand experience with quality tools, data, and processes and can use those tools to influence design outcomes and improvements across the organization
• Excellent ability to interface with and influence cross-functional team members and work in a fast-paced, multi-disciplinary environment
• General knowledge of at least one mainstream language (preferred proficiency in C, C , Java, or Python)
• Desired Qualifications:
• Experience with test automation tools such as Appium, Selenium, Cucumber, etc.
• Experience with test management tools
• Experience with continuous integration and continuous deployment (CI/CD)
• Familiarity Cybersecurity of medical devices
• Experience in computerized system validation under GAMP 5
• Quality Engineering Certification, Software Quality Engineering Certification (e.g., ASQ CQE, ASQ CSQE)

Working Conditions

General office environment

Physical Requirements

If the job is physically demanding, this should be stated in the job description. A physically demanding job is one where the incumbent is required to stand for extended periods of time, lift heavy objects on a regular basis, do repetitive tasks with few breaks, and so forth.

BENEFITS

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.

At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.

As part of our commitment to diversity, equity, and inclusion, Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $120,000 to $150,000. We may ultimately pay more or less than the posted range. Actual compensation packages are based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.

Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at Careers@biolinq.com