Sr. Systems Engineer

Pattern Bioscience • Austin, TX

295d

About The Position

At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time. Our technology rapidly identifies bacterial infections and predicts the most effective antibiotics to treat the infection. We’re building direct-from-specimen phenotypic rapid ID/AST assays using live cells on our proprietary instrument and consumable platform. We are looking for a teammate, a problem solver, someone who is persistent, passionate, and loves to see projects to completion. As the Senior Systems Engineer, you will join our Hardware Engineering team working on our platform instrument and bring your deep experience in system engineering to support and lead efforts as we transition our diagnostic device from development to production. You will apply broad systems level knowledge in collaboration with design engineers, Assay Development, Software, Clinical Affairs, Quality, Regulatory and Manufacturing to improve product functionality, reliability, and manufacturability. This role is for you if you think cohesively about a device, translating requirements and user needs to the product. You also get hands-on with the device and are especially interested in the intersection of software and hardware engineering.

Requirements

• B.S. in Mechanical, Electrical, or Biomedical Engineering. M.S. is preferred.
• 6+ years of industry experience including working on new product design and development for medical device or in-vitro diagnostic (IVD) devices from concept phase through production, especially working through verification and validation phases through commercialization
• Thorough knowledge of and experience applying one or more of the following 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 including optical, electrical, thermal, mechanical, and software
• Proficiency in Python or equivalent language for data manipulation and visualization
• Experience with FMEA/SolidWorks, and/or optical or thermal system design a plus

Responsibilities

• Lead development of verification protocols and completion of testing alongside our software, mechanical, and electrical engineering teams
• 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 with support of the software, electrical and mechanical engineering teams
• Track and trend performance data across prototype and production systems to support prioritization and planning for reliability improvement efforts
• Update risk and hazard analysis documentation such as Failure Modes and Effects Analysis
• Develop system requirements for future and current products 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

Benefits

• Health insurance
• 401k Matching
• Paid Time Off
• The opportunity to make a global impact

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree