Quality Engineer IV

Remote              ·             Full time

What you will be doing: 

Beacon is searching for an engineer to become an integral part of Beacon’s Quality Assurance domain. The role will work closely with Beacon’s Platform, Hardware, and Algorithms domains. This engineering role will reside and live in Beacon’s Quality Assurance domain – but hang on! This isn’t your run-of-the-mill quality engineering role; we don’t do “check-the-box” functions here. Beacon needs you to serve a key role in developing, integrating, and implementing quality product planning into the entire product lifecycle for our engineering teams and to take an active role in incorporating these activities into our Quality Management System. Quality is a core driver in how we build safety, efficacy, and reliability in the solutions we are building to enable new treatments for patients.

This is a remote friendly position. Beacon’s robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston and New York.

What success looks like: 

• Ongoing support of a CFR Part 820 and ISO 13485 compliant QMS
• Review Design Control documentation deliverables with a focus on requirement documents, risk assessment and V&V protocols and reports
• Develop a core understanding of Beacon’s hardware, firmware, mobile, and cloud systems to help ensure sustainable product lifecycle processes
• Work with the hardware engineering team and suppliers on development & verification and translate that into QA/QC criteria for routine production and reliability monitoring
• Support development of verification and validation plans and protocols of hardware and firmware and software aligned with industry standards
• Develop and execute on the system quality and risk management plans
• Track field performance, reliability, complaints, corrective actions; report on metrics and close issues with continuous improvement mindsets
• Work with suppliers to address changes, nonconformances and as necessary implement corrective actions
• Perform supplier qualification activities, including evaluations and audits
• Support QMS process, work instruction, CAPA, and other documentation building and maintenance
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What you will bring: 

• 5-7+ years of experience 
• BS in Biomedical, Electrical, Systems, or similar Engineering field preferred and 7+ years experience in the following:
• Experience in QA and/or testing, and validation of firmware and hardware devices
• Experience developing, manufacturing, and/or developing quality testing for digital health, medical device hardware/software on wearable medical or consumer products
• Experience with IEC 60601, 80601 and electrical medical device safety principles
• Experience with ISO 62034 and/or SaMD and software validation
• Experience working under quality system such as ISO 13485 or 21 CFR 820
• Experience with product level risk assessment under ISO 14971 and IEC 60601-1
• You are equally excited about validation, reliability, and breaking things as you are about process and documentation to support the hardware and software
• You know that quality assurance system foundations are essential to building reliable products for customers, and ultimately patients
• You enjoy building new processes or fixing old processes to improve quality products and team efficiency and operations
• You have worked in a regulated environment (Medical Device, Aerospace, etc)
• Experience with wearable sensors a plus
• Exposure to PCBA, SMT, final device assembly, a plus

At Beacon, we’ve found that cultural and scientific impact is driven most by those that lead by example. As such, we’re always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and – most of all – a deep empathy towards colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact.

Please click here to apply.