What you will be doing:
Beacon is searching for a senior engineer to become an integral part of Beacon’s Hardware and Algorithms domains. This role will reside and live in the department of Quality -- hang on! This is not 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 Hardware and Algorithms teams and to take an active role in building this as a collaborative system. Quality is a core driver in how we build safety, efficacy, and reliability in the solutions we seek to enable new treatments for patients.
This is a remote first position located in the continental United States. 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:
- Develop a core understanding of Beacon’s embedded hardware/firmware and device systems
- Work with the hardware engineering team and suppliers on development test and translate that into QA/QC criteria for routine production and reliability monitoring
- Work with development to integrate early testing into prototypes and development planning and transfer that to design reliability test plans and targets
- Develop verification and validation plans of hardware and firmware and software aligned with industry standards
- Integrate early testing into prototypes and development working with the Hardware development team.
- Document test cases and code used for test execution and build into design transfer for routine product lifecycle activities
- 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
- Support QMS process, work instruction, CAPA, and other documentation building and maintenance
What you will bring:
- Minimum BS in Electrical, Software, and/or Systems Engineering
- Experience writing and/or testing firmware and hardware required
- Experience with PCBA, SMT, final device assembly required
- Experience as a development engineer and/or reliability engineer for medical device hardware with embedded systems
- Experience developing and/or developing quality testing for digital health, medical device hardware/software or QA on wearable medical or consumer products
- Testing automation using Python or similar
- Strong applied knowledge of debugging tools and testing development
- Software analysis and validation
- Experience with of IEC 60601, 80601 and electrical medical device safety principles
- Experience with ISO 62034 and/or SaMD
- Experience with quality systems such as ISO 9001, ISO 13485, or 21 CFR 820
- You are equally excited about testing, 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
- Experience with wearable sensors a plus
- You have worked in a regulated environment (Medical Device, Aerospace, etc)
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.
