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Electronics Quality Engineer

Summary of Position

As the Electronics Quality Engineer (full remote work schedule) you will ensure the quality of electronics- and optoelectronics-based medical devices, supporting contract manufacturing sites and AccuVein’s San Jose facility. You will focus on sustaining engineering, including product redesigns, manufacturing process improvements, cost-saving projects, and resolving quality issues. You will be expected to collaborate with cross-functional teams, contributing to all phases of Product Development and providing guidance to ensure project success. Additionally, you will work closely with Quality Assurance, Regulatory, Sales, Marketing, and customers to troubleshoot complaints and maintain operational excellence through adherence to best practices and standard procedures.

Responsibilities

  • Analyzing and improving electronics to meet target quality outcomes
  • Troubleshooting FPGA-driven electronics and optoelectronics.
  • Assessing and improving current processes
  • Improving and designing production equipment
  • Implementing component qualifications, sampling plans, and test strategies
  • Support new product transfer activities, including process qualification.
  • Document, verify, and validate mechanical, optical, and electrical designs and their related processes.
  • Key participant in DFMEA, PFMEA, and CTQ processes assuring specifications are well defined and documented.
  • Detailed working knowledge of statistics and be able to develop and apply mathematical or statistical theory and methods to collect, organize, interpret, and summarize numerical data to provide usable information.
  • Mine and analyze production and quality data for trends, hypothesis testing, process capability, ANOVA, etc.
  • Establish and maintain control plans, including CTQs, CPPs, SPC, and KPIs for product and process quality.
  • Investigate product and process quality in order to make improvements to achieve better customer satisfaction and oversee continuous improvement projects.

Education and Experience

  • 8-10 years in Medical Devices or a similarly regulated field, with a production and sustaining engineering background.
  • 5-10 years in electronics.
  • Bachelor’s degree in Electrical engineering, Biomedical Engineering, Physics, or Mathematics.
  • Proficiency in circuit and PCB design using Altium and SMT production equipment and processes; familiarity PCB inspection equipment.
  • Expertise in medical device quality management and Quality Management Systems, with advanced knowledge of PLM tools like Arena and Agile.
  • Skilled in Lean Six Sigma, Practical Statistics, Minitab, and managing external suppliers.
  • Experience managing external suppliers and contract manufacturers and directing resources remotely.

Benefits

AccuVein values our employees' time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits. We work to maintain the best possible work environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person can feels encouraged to contribute to our processes, decisions, planning and culture.

About AccuVein

AccuVein Inc. is the global leader in vein visualization. AccuVein’s flagship product, the AV500, was released in 2019, making it the latest in vein illumination technology. It is built on proprietary technology as embodied in the company’s growing patent portfolio, which currently consists of over 50 issued patents, covering a broad range of imaging and medical diagnostic technologies. AccuVein is now the standard of care in many facilities around the world.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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