MENU

Senior Quality Engineer Seattle

 

We are seeking a Senior Quality Engineer. The primary part of the job will be leading and/or directly contributing to the quality aspects of a medical product’s design. Specific technical responsibilities vary by project, however it is imperative that you have command of all quality engineering fundamentals and understand how they are applied to highly reliable documented design.

Job duties include: 

  • Manage the creation and release of quality engineering documentation that meets or exceeds established industry standard best practices
  • Collaborate with multi-discipline team members to ensure product development plan objectives and deliverables are achieved
  • Support the Quality System Manager (QSM)
  • Develop verification test plans, protocols, and reports
  • Train personnel assigned to generate or execute verification test protocols
  • Develop and manage appropriate requirements specifications at both the system and design level
  • Develop risk management plans, risk/hazard analysis, fault tree analysis, and FMEA documents
  • Support customer with post-verification tasks (design validation, manufacturing/production test development)
  • Provide accurate quality engineering and testing activity estimates for project quotations
  • Interpret and articulate applicable agency requirements
  • Actively participate in project design and phase reviews

Qualifications:

  • Bachelor’s of Science degree in Electrical, Software or Mechanical Engineering from an accredited four-year university (or equivalent)
  • 5+ years of experience in medical device development
  • Have a working knowledge of the FDA Quality System Regulations and Design Control Requirements
  • Have a working knowledge of the IEC/UL/AAMI 60601-1 Medical Device Safety Standard
  • Have a working knowledge of 21 CFR 820 (Quality System Regulation for Medical Devices), ISO 13485 (Quality Management Systems – Requirements for Regulatory Purposes), ISO 14971 (Medical Devices – Application of risk management to medical devices), and IEC 62304 (Medical device software – Software lifecycle process)
  • Excellent organization and analytical skills combined with attention to detail. Ability to prioritize and plan effectively.
  • Highly motivated with demonstrated ability to work independently with minimal supervision
  • Ability to communicate clearly and write detailed reports
  • Have a positive attitude and focus on client success
  • Ethical and honest in every part of the job
  • Work effectively in a team setting and collaborate openly with other engineers

Other Experience:

  • Software, Electrical, or Mechanical medical device design experience a plus
  • Auditor Certificate for ISO 13485 and/or AS9100 a plus
  • Development of embedded software or software test applications where product safety and risk controls are paramount a plus
  • Experience with Atlassian tools (Confluence, JIRA) a plus

Benefits:

In addition to competitive pay, we offer:

  • Healthcare plan (Medical, Dental, and Vision)
  • 401(k) plan with matching
  • Long-term and short-term disability, AD&D and Life Insurance
  • 11 Paid holidays
  • 3 weeks of paid time off (PTO) per year, increasing after 2, 5, and 10 years of service

We work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.

To Apply: 

To respond to this opportunity, please send your resume and cover letter to jobs@simplexitypd.com.

Location is in Seattle, WA. Some travel and/or on-site work at client sites may be required for this position.