“Biodesix requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under state and federal law.

This requirement is a condition of employment at Biodesix, and it applies regardless of whether the position is located at a Biodesix site, field based or is fully remote. If you are unable to receive the vaccine due to a medical condition (including pregnancy-related), or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation from Human Resources.”

ABOUT US:

Biodesix is a leading diagnostic company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer six non-invasive tests for patients with diseases of the lung. Biodesix launched the SARS-CoV-2 ddPCR™ test and the Platelia SARS-CoV-2 Total Ab in response to the global pandemic and virus that impacts the lung and causes COVID-19. The blood based Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment. The blood based Nodify Lung™ nodule risk assessment testing strategy consisting of the Nodify XL2™ test and the Nodify CDT™ test evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. Biodesix also collaborates with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, please visit www.biodesix.com.

OBJECTIVE OF THE POSITION:

This position manages quality policies, procedures, processes, programs, and practices associated with product realization activities (including pre and post launch) and documentation to demonstrate conformance with appropriate standards and regulations. The Quality Engineer II is responsible for supporting product development teams in the design practices and risk and hazard management processes associated with development of assays, diagnostic test services and software algorithms per the Biodesix Quality Management System (QMS).

REGULATORY REQUIREMENTS:

This role shall comply, at a minimum, with the responsibilities outlined in:

• CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493

• CAP: College of American Pathologists (CAP): All Common, General, Chemistry, Director Responsibility and Authority and Molecular Pathology checklists

• NYS CLEP: New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP), New York State Public Health Law, Article 5 Title 5

• ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016 

• All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD.

RESPONSIBILITIES:

The Quality Engineer II is responsible for quality assurance throughout product lifecycle including but not limited to: process validation, equipment qualification, risk activities, and supplier qualification. This position may be required to act as the lead functional Quality representative on product development Core Teams. In that capacity, they must be a collaborative leader with assays, software algorithms, diagnostic test service for LDT and/or IVD experience in design practices, risk, and hazard management. They are accountable to ensure all documentation related to validation, supplier management, and other quality management activities, are structured and organized in accordance with document control procedures and design practices appropriate for the current business of Biodesix.

The Quality Engineer II must have the judgment to prioritize activities based upon risk and resources available. While training and education at a large medical device manufacturer a plus, must have the ability to translate that experience into a smaller, earlier stage firm in a nimble, fast-moving environment with products subject to different regulations ranging from FDA to CAP/CLIA and NYS CLEP.

The products developed by the Company are high complexity Laboratory Developed Test (LDT) diagnostic services and, to that end, experience with diagnostic test systems including assays, instrumentation and software and validation thereof according to CAP/CLIA, NYS CLEP, and various IVD guidance documents is critical. The role will communicate and coordinate with marketing, development, lab operations and Laboratory Directors to ensure appropriate documentation of test/process/equipment validation.

ESSENTIAL FUNCTIONS:

• Day-to-day management, development, and implementation of quality assurance programs by the Company.

• Deliver against Company goals to ensure core team projects are completed on time and meet the Company's quality standards.

• Strong collaboration with operations, other managers, engineers, and product development staff.

• Monitor production and purchasing services or activities to improve accuracy, customer service, or safety.

• Development of validation plans for equipment, software, and process.

• With Operations and Development leadership, examine existing procedures or opportunities for streamlining activities to meet product improvement needs.

• Contributor as the Quality function on verification & validation plans and reports.

• Leading the development of the risk management plan(s) for product realization.

• Assisting project teams on compliance with design requirements per CAP/CLIA, NYS CLEP and FDA QSR, European MOD, ISO l3485, ISO 14971, and other applicable ISO/EN standards as applicable to the Company.

• Accountable for the following key functions within the Quality team Product Development Process:

o Design Control SOPs

o Device Design History Files

o Risk Management

o Software Risk Management

o Quality/Process Improvement and Validation

o Supplier and Material Management

o Lab Operation processes that impact quality

COMPETENCY OR POSITION REQUIREMENTS:

• Knowledge and experience with (CAP/CLIA, NYS CLEP) LDT, QSR and PDP.

• Good working knowledge of object-oriented concepts and application design principles.

• Clear understanding and experience implementing ISO 14971:2019 Risk Management into a QMS.

• Working knowledge of developing equipment and/or process master validation plans.

• Must be a team player with strong customer orientation and ability to work within a diverse disciplinary cross-functional team environment.

• Ability to work with a small team and/or work as an individual contributor.

• Strong verbal, written, organizational, time management and interpersonal skills.

• Experience with creation and execution of testing plans/reviewing functional specification documents.

• Experience managing multiple supplier qualifications, reassessments, and correction actions.

• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.

• Experience with testing automation solutions.

• Must be able to communicate effectively in a verbal and written format.

• The successful candidate will be:

o Able to perform all the required skills of this position with minimal direction.

o A motivated self-starter.

o A detail oriented and quality minded individual with experience based good judgment.

o Strong computer skills, including working knowledge of MS Office and e-mail.

EDUCATION AND EXPERIENCE:

• Bachelor of Arts or Science in Life Sciences, Engineering or Business Management.

• Minimum of 2 years design quality engineering experience in the regulated industry, with 2+ years QA practice.

UNPLANNED ACTIVITIES:

• Other duties as assigned. 

OTHER:

This position is eligible for both annual equity awards and our short-term incentive program.

Biodesix provides paid healthcare, including medical, dental and vision, and a competitive paid vacation and sick leave program. Please visit our website for additional details. www.biodesix.com/careers/benefits

Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.