About the position
Beacon is seeking an engineer to join their Quality Assurance domain and play a crucial role in developing and implementing quality product planning throughout the entire product lifecycle. This is not a typical quality engineering role, as Beacon emphasizes the importance of incorporating quality into their solutions for patient treatments. The successful candidate will support a compliant Quality Management System, review design control documentation, collaborate with hardware engineering teams and suppliers, and contribute to system quality and risk management plans. This is a remote-friendly position with office hubs available in Boston and New York.
Responsibilities
- 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
Requirements
- 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
- 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 devices, or related industries.
Benefits
- 5-7+ years of experience
- BS in Biomedical, Electrical, Systems, or similar Engineering field preferred and 7+ years experience
- 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
- Exposure to PCBA, SMT, final device assembly, a plus
- Cultural and scientific impact driven by leading by example
- Avid curiosity
- Bias towards simplicity
- Eye for composability
- Self-service mindset
- Deep empathy towards colleagues, stakeholders, users, and patients
- Belief in the power of a diverse team to build more robust systems and achieve higher impact