Associate Software Design Quality Engineer

Job Title: Associate Software Design Quality Engineer

Location: Onsite in Boulder, CO

About Our Company

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About The Role

Foresight is seeking an Associate Software Design Quality Engineer to support the Quality Assurance team. The Associate Software Design Quality Engineer is part of software quality engineering team providing quality and compliance support to ensure products are developed per FDA 21 CFR Part 820, ISO 13485:2016, ISO:14971, and other applicable regulations. The ideal candidate has introductory level experience in applying software quality practices to regulated medical device products or introductory experience applying software development life cycle methodologies in a regulated environment. This role supports the completion of software risk analysis, assists with conducting root cause analysis for non-conformances, deviations, Corrective and Preventive Actions (CAPA), and supports internal and external audits.

What You Will Do

• Support the review of software deliverables for the Design History File for product launches for compliance with Quality System and Design Controls principles.

• Review software product requirements to ensure acceptance criteria and internal procedures have been met and are compliant with applicable regulations.

• Collaborate with the cross-functional teams to lead risk management activities and establish risk documentation per ISO 14971 for new product/service development projects to support regulatory submissions.

• Assist in the completion and maintenance of software risk files and other supporting deliverables.

• Support product development team with quality assessments of design changes, non-conformances, and impact on design history files and risk management files, as assigned by management.

• Assist with software opportunities for continuous improvement projects and Corrective & Preventative Action(s) (CAPA).

• Participate in FDA inspections, Notified Body audits, and other internal and external audits.

What You Will Bring

• Bachelor’s degree in software engineering, computer science, information technology or related field.

• Minimum 1-3 years of experience in a diagnostic, medical device, or life sciences technology driven company.

• Introductory level experience in applying software quality practices to regulated medical device products or introductory experience applying software development life cycle methodologies in a regulated environment.

• Experience with root cause analysis techniques and risk management tools (i.e. FMEAs, system hazard analysis) is preferred.

• High attention to detail.

• Ability to work independently or as part of a cross-functional team in a fast-paced, changing environment.

• Growth mindset with curiosity, adaptability and willingness to learn.

Physical and Mental Requirements, Working Conditions

• Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This position requires close visual acuity to perform activities such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

Compensation and Benefits

This role is hiring at an annual salary of $70,000 - $90,000 and is eligible for bonus and equity offerings.

The hiring salary range is applicable across the continental United States. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States.

Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.

You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.