Sr. Software Quality Engineer- Med Device - Diagnostic Exp Required

Job Title: Senior Software Quality Engineer - Software & Systems Focus
Location: Austin, TX
Department: Quality

At Pattern Bioscience, we're tackling antibiotic resistance-one of the CDC's top public health threats. Using AI and single-cell analysis, we identify pathogens and predict effective treatments in record time. We're deeply committed not only to revolutionizing healthcare decisions but also to supporting and growing the incredible team behind the mission.

We're seeking a Senior Software Quality Engineer with strong experience in software quality, regulatory compliance, and risk management in the IVD or Software as a Medical Device (SaMD) space. This individual will help bridge our transition from a startup research environment to a fully FDA-compliant development and manufacturing organization.

This role is ideal for someone who thrives in a dynamic, collaborative setting and is passionate about building quality into every stage of the product lifecycle-from concept through commercialization.

How You Will Contribute

Immediate (90-Day) Priorities

• Developing release readiness checklists and implementation plans for deploying new software releases.

• Review and enhance risk assessments (e.g., FMEA, hazard analysis) and test plans for software and hardware systems.

• Update traceability matrices, collaborate in requirements definition, and initiate a Master Validation Plan.

• Lead the creation of detailed design documents capturing the implementation of software requirements.

• Mid-Term (6-Month) Goals

• Support development and implementation of software-related change control and design change procedures.

• Consolidate and improve tools for defect tracking and requirements management.

• Lead validation activities for non-product software, including writing protocols, coordinating testing, and writing reports.

General Responsibilities

• Ensure software development aligns with key regulatory standards:

• 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971

• Lead test strategy development and execution for unit, integration, and system-level testing.

• Mentor junior quality engineers and foster a culture of compliance and continuous improvement.

Must-Have Qualifications

• Experience at an IVD company or in Software as a Medical Device (SaMD).

• Demonstrated experience supporting products from concept through market release.

• Strong knowledge of FDA and international software regulations, with hands-on audit preparation experience.

• Understanding of cybersecurity concerns in regulated medical software.

• Proficiency with quality tools and risk management frameworks (e.g., 8D, Ishikawa, FMEA).

We'd Love to Hear from You If You:

• Build consensus across technical and regulatory teams.

• Are proactive, adaptable, and solution-oriented.

• Thrive in complex, regulated environments where innovation is key.

• Communicate clearly and confidently, especially in technical writing.

• Have a passion for quality, problem-solving, and protecting patient safety.

Education and Experience

• B.S. in a technical, software, or life sciences discipline.

• 6-9 years in a quality role within a regulated biotech or medtech company.

• Preferred: ASQC Certification, or Lead Auditor Certification.

• Desired: Six Sigma Black Belt or ScrumMaster,

Benefits

• Medical, Dental, and Vision Insurance

• 401(k) Matching

• Personalized PTO

• Career Development Opportunities

• The chance to make a global impact and pioneer solutions

Learn more about us: https://pattern.bio/join-us/

We value diversity. All qualified applicants will receive consideration for employment regardless of race, religion, color, national origin, sex, gender identity, sexual orientation, age, disability, veteran status, or any legally protected characteristic.