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Senior Systems Engineer

2 months ago

Austin, Texas, United States Pattern Bioscience Full time
About the Role

We are seeking a highly skilled Senior Systems Engineer to join our Hardware Engineering team at Pattern Bioscience. As a key member of our team, you will be responsible for leading the development of verification protocols and completing testing alongside our software, mechanical, and electrical engineering teams.

Key Responsibilities
  • Lead development of verification protocols and completion of testing
  • Analyze performance metrics across diagnostic devices to inform design changes and updates to the manufacturing processes
  • Guide and support qualification of diagnostic devices for clinical evaluations
  • Plan, coordinate, execute, and document verification and validation testing
  • Track and trend performance data across prototype and production systems
  • Update risk and hazard analysis documentation
  • Develop system requirements from user needs, technology capabilities, and engineering constraints
  • Manage engineering technician tasks related to performance testing, verification testing, and reliability testing
  • Formalize reporting for regulatory submissions
Requirements
  • B.S. in Mechanical, Electrical, or Biomedical Engineering. M.S. is preferred.
  • 6+ years of industry experience in new product design and development for medical device or in-vitro diagnostic (IVD) devices
  • Thorough knowledge of and experience applying FDA or industry standards: ISO 13485, 21 CFR Part 820, ISO 14971, ISO 61010, and/or ISO 60601
  • Experience with development and integration of medical device systems that require multiple engineering disciplines
  • Proficient in Python or equivalent language for data manipulation and visualization
  • Experience with FMEA/SolidWorks, and/or optical or thermal system design a plus
What We Offer
  • Health insurance
  • 401k Matching
  • Paid Time Off
  • The opportunity to make a global impact

We value diversity on our teams and are committed to creating an inclusive environment where everyone can thrive. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, neurodiversity, status as a qualified individual with disability, protected veteran status, hair texture or protective hairstyle, or any other characteristic protected by law.