Quality Engineer IV

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 be responsible for supporting a compliant Quality Management System, reviewing design control documentation, and working with hardware engineering teams and suppliers to ensure production and reliability monitoring. Additionally, they will contribute to the development and execution of verification and validation plans aligned with industry standards, track field performance and close issues with a continuous improvement mindset.

• 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, medi

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, or similar regulated products

• 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, and deep empathy towards colleagues, stakeholders, users, and patients
• Belief in the importance of a diverse team for building robust systems and achieving higher impact