What are the responsibilities and job description for the Design Quality Engineer I position at Biodesix?

ABOUT US :

Biodesix is a leading diagnostic solutions 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 offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate 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.

OVERVIEW :

The Design Quality Engineer I manages quality policies, procedures, processes, programs, and practices associated with product realization and design control activities (including pre and post launch) and documentation to demonstrate conformance with appropriate standards and regulations. The Design Quality Engineer I 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, specimen collection kits, and software algorithms per the Biodesix Quality Management System (QMS).

JOB LOCATION

Louisville, CO - On-Site

RESPONSIBILITIES :

Day-to-day management, development, and implementation of quality assurance programs by the Company.
Represent quality assurance on product development core teams
Deliver against Company goals to ensure core team projects are completed on time and meet the Company's quality standards.
Strong collaboration with other managers, engineers, operations, and product development staff.
Monitor production and purchasing services or activities to improve accuracy, customer service, or safety.
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 for product realization.
Assisting project teams on compliance with design requirements per CAP / CLIA, NYS CLEP and FDA QSR, European MOD, ISO l3485 and other applicable ISO / EN standards as applicable to the Company.
Accountable for the following key functions within the Quality team Product Development Process :

Design Control SOPs

Device Design History Files

Risk Management

Software Risk Management

Quality / Process Improvement and Validation

Supplier and Material Management

Lab Operation processes that impact quality

Create and Update Individual Quality Control Plan(s) (IQCP) for each product on the market

Other duties may be assigned as deemed necessary by the supervisor.

REQUIREMENTS :

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

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 : 2012 Risk Management into a QMS

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 :

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

A motivated self-starter.

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

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

EDUCATION AND EXPERIENCE :

Bachelor of Arts or Science in Life Sciences or Engineering

COMPENSATION :

Annual compensation range $72,800 to $85,700

Discretionary Bonus opportunity

Comprehensive health coverage : Medical, Dental, and Vision

Insurance : Short / Long Term Disability and Life Insurance

Financial benefits : 401(k), Flex Spending Account

120 hours of annual vacation

72 hours of paid sick time off

11 paid holidays 3 floating holidays

Employee Assistance Program

Voluntary Benefits

Employee recognition program

Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.

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.

Salary : $72,800 - $85,700

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