Sr. System Engineer

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.
Below you'll find a few ways you can make an immediate impact.
Goals (First 90 Days)

• 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

How You Will Contribute

• 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 Analyses
• 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

We'd Love to Hear from You if You

• Love data and driving changes based on analysis
• Understand and correctly apply design control and risk management practices
• Recognize and use statistics and experimental design appropriate for system engineering
• Build rapport to collaborate with stakeholders across disciplines and generate alignment
• Think big picture and strategically navigate compliance with requirements and product feasibility
• Persuade others by contextualizing decisions and requirements
• Deeply enjoy solving system-level problems, finding creative solutions across disciplines, and tracking down root causes
• Communicate technical and non-technical information well in both written and oral formats to individuals with a variety of technical backgrounds
• Plan and manage multi-faceted projects involving other teams and disciplines with strong attention to detail and a focus on quality and deadlines

Desired Education & Experience

• 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
• Proficient in Python or equivalent language for data manipulation and visualization
• Experience with FMEA/SolidWorks, and/or optical or thermal system design a plus

Join us! We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website.
Benefits
* Health insurance
* 401k Matching
* Paid Time Off
* The opportunity to make a global impact
To fulfill our mission and build world-changing technology, we've put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.
We value diversity on our teams. 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.