Software Quality Engineer IV

Summary

Join Beacon Biosignals, a leader in at-home EEG platforms for clinical development, as a Software Quality Engineer. Reporting to the VP of Quality, you will be embedded within software and machine learning squads, ensuring compliant development and aligning with regulatory obligations. Lead the maintenance and evolution of software compliance processes throughout the product lifecycle. Provide company-wide training on SDLC practices and risk management, and represent Beacon in audits. Keep pace with international regulatory changes and translate that knowledge into actionable improvements. Oversee software tool validation and coordinate product releases. Foster alignment and communication across the Quality function and the organization. Beacon offers a robust asynchronous work model with in-person office hubs in Boston and New York.

Requirements

• Minimum of 5 years of experience in a software quality environment within the medical device industry
• Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills
• Demonstrated experience implementing IEC 62304
• Certified software quality engineer (CSQE)
• Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, and ISO 14971
• Bachelor’s degree in a relevant scientific, engineering, or related field
• A strong intellectual curiosity with the ability to quickly grasp complex concepts, contribute to shaping the quality team, and thrive in a dynamic space
• Exceptional interpersonal and relationship-building abilities, with a talent for managing projects and guiding decisions across multiple internal and external stakeholders
• Strong analytical, organizational, and communication skills, with a demonstrated ability to adapt effectively to changing circumstances

Responsibilities

• Support company goals by ensuring projects and products are delivered on time, within scope, and in full compliance with applicable regulatory and internal requirements
• Provide pragmatic, solutions-oriented guidance that enables teams to move quickly without sacrificing quality
• Drive scalable quality processes that evolve with Beacon’s software and machine learning platforms
• Anticipate and mitigate compliance risks before they become roadblocks
• Collaborate effectively across teams to build trust and alignment around quality initiatives

Benefits

• Equity
• PTO
• Other benefits
• Beacon's robust asynchronous work practices ensure a first-class remote work experience