Beacon Biosignals · 3 weeks ago
Quality Engineer IV
United States
Full-time
Remote
Senior Level, Lead/Staff
8+ years expBeacon Biosignals is on a mission to revolutionize precision medicine for the brain, and they are seeking a Quality Engineer IV to support their quality department. The role involves ensuring compliance in hardware and software processes, leading teams in product development, and coordinating product releases while maintaining regulatory standards.
Artificial Intelligence (AI)Health CareHealth DiagnosticsMachine LearningMedical Device
Responsibilities
SME for hardware and software compliance processes across design, manufacturing, product release, and post market support
Leading and providing guidance to the Software, Machine Learning, and Hardware teams for new product development and sustaining engineering to support Beacon goals, collaborating closely with engineering leadership
Improving processes for compliance, implementing the least burdensome approach
Representing Beacon in second (customer) and third party audits (ISO auditors) as well as inspections by regulators as the SME in relevant areas
Staying current on changes to international standards and regulations, communicating insights and awareness to broader organization
Collaborating and aligning within the quality team and across the company
Coordinating product releases in collaboration with Software, Machine Learning, and manufacturing teams
Coordinate Product Releases: Collaborate with engineering and machine learning teams to plan, execute, and document product releases
Support Product Development Teams: Provide expertise in the design of regulated products, ensuring compliance with quality standards
Consult Across Teams: Act as a quality and compliance consultant for engineering, machine learning, and manufacturing teams throughout design and process control
Ensure Timely Project Delivery: Drive efforts to ensure projects are completed on time, within scope, and in compliance with all regulatory requirements
Qualification
Required
Minimum of 8 years of software experience in a quality environment within the medical device industry
Proven ability to work autonomously with hands-on problem solving expertise and strong analytical skills
Working knowledge of key industry standards and regulations, including 21CFR 820, ISO 13485, IEC 60601, IEC 80601, TIR45, and ISO 14971
Bachelor's degree in a relevant scientific, engineering, or related field
Demonstrated experience implementing IEC 62304
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
Preferred
Certified software quality engineer (CSQE) or Certified Quality Engineer (CQE), preferred but not required
Knowledge of European regulatory requirements such as IVDR or MDR, including CE mark process
Benefits
Equity
PTO
Other benefits
Company
Beacon Biosignals
Beacon Biosignals is a neurotechnology company that brings precision neuroscience into clinical trials and treatments.
51-200 employees
H1B Sponsorship
Beacon Biosignals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Growth StageTotal Funding
$116MKey Investors
General Catalyst
2025-11-13Series B· $86M
2021-11-08Series A· $27M
2019-06-01Seed· $3M
Leadership Team
Jacob Donoghue, MD PhD
Co-Founder and CEO
M Brandon Westover
Co-Founder
Recent News
Longevity.Technology - Latest News, Opinions, Analysis and Research
2025-12-19
MarketScreener
2025-12-16
Company data provided by crunchbase