Elucent Medical Inc-posted about 2 months ago
$80,000 - $90,000/Yr
Full-time • Mid Level
Onsite • Eden Prairie, MN
Computer and Electronic Product Manufacturing

The Quality Engineering Technician leads the Quality activities required for medical device development and manufacturing. This role provides hands-on experience in quality engineering fundamentals and performs Quality engineering activities such as data collection, statistical analysis, writing technical documentation, and development and execution of test and validation protocols. The position also includes the ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; and give oral presentations. The technician leads independently on core engineering technician practices, contributes to process improvements, and performs Quality activities within design and manufacturing controls for a regulated environment. This position shall author engineering protocols and reports. Possess the ability to work on multiple tasks and projects with effectiveness and efficiency. Responsibilities include performing complex validations, Gage R&R studies, supporting measurement system analysis, process characterization studies, identifying trends, advanced writing skills, and assisting with investigations or testing related to product, design, or process performance projects. The role may also provide support for quality operations and production activities as needed. Additionally, the technician assists in the administration of quality system processes within the electronic Quality Management System (eQMS), ensuring activities and change requests are accurately documented and completed in a timely manner. Other duties may be assigned.

  • Independently author, review and approve complex quality protocols, validation plans and reports. Provide technical mentorship and ensure alignment with regulatory and organizational standards.
  • Lead verification, validation and method development initiatives. Define test strategies, establish acceptance criteria, and interpret complex data to guide engineering decisions.
  • Lead cross-functional teams to develop, optimize and implement quality SOPs and manufacturing/test instructions. Mentor junior technicians in document control and compliance practices.
  • Design, execute and statistically analyze advanced measurement system analyses (e.g., Gage R&R , capability studies, DOE). Provide recommendations to improve measurement reliability and process control.
  • Work from drawings, solid models, written and verbal descriptions or defined plans to perform testing and troubleshoot functions. Collaborate closely with design, manufacturing and quality engineering to proactively identify and resolve design for manufacturability and quality challenges.
  • Apply advanced statistical tools (e.g., ANOVA, regression, SPC) to identify process trends and drive continuous improvement initiatives.
  • Develop and maintain data reporting systems and dashboards. Translate data into actionable insights for product and process optimization.
  • Lead root cause analyses and CAPA activities, developing corrective/preventive strategies. Provide technical guidance to teams to prevent recurrence and enhance product reliability.
  • Ensure quality system documentation and record-keeping activities comply with established procedures and work instructions.
  • Proactively identify opportunities for process and product improvement, driving initiatives to enhance operational excellence and compliance.
  • Demonstrate safe work practices and maintain a clean, organized work area.
  • Perform other duties as assigned by the manager.
  • Associates or Technical degree with a minimum of 10+ years of progressively responsible experience in the medical device industry under ISO 13485 and related regulatory standards (FDA, QSR, EU MDR).
  • Demonstrated understanding of quality system principles, risk management and validation practices within regulated environments.
  • Advanced math and analytical aptitude, with proven ability to apply statistical tools to support process capability, Gage R&R, and data-driven decision making.
  • Proficient with digital tools and technical software, including Microsoft Office applications, Minitab, and Visio.
  • Exceptional technical communication skills - able to author, review and approve quality protocols and technical summaries that meet internal and regulatory documentation standards.
  • Experience providing cross-functional support to design, manufacturing, and quality engineering teams, including leading verification/validation activities, troubleshooting, and root cause analyses.
  • Strong background in an electronics manufacturing, with a comprehensive understanding of electrical and mechanical testing methods and instrumentation.
  • Demonstrated ability to mentor junior staff, lead quality initiatives and drive continuous improvement.
  • Proven track record of independent problem solving, ownership of complex quality activities and consistent delivery of results in dynamic, highly regulated settings.
  • Maintains a positive professional attitude when working with peers.
  • Comfortable working in a self-directed team environment and giving or asking for instructions.
  • Demonstrate an understanding of the medical device industry.
  • Works effectively on cross-functional teams to establish appropriate processes pertaining to quality.
  • The individual must have a hands-on approach.
  • Strong organizational and time management skills.
  • Ability to work on multiple tasks and projects with effectiveness and efficiency.
  • Excellent written and oral communication skills.
  • Positive and cooperative communications and collaboration with all levels of employees, contractors and suppliers.
  • Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions.
  • 401(k)
  • 401(k) matching (4%)
  • Dental insurance
  • Health insurance
  • Vision insurance
  • Paid Holidays
  • Paid Vacation Days
  • Paid Sick Days
  • Short Term Disability
  • Long Term Disability
  • Life Insurance
  • Pet Insurance
  • Employee Assistance Programs
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