Staff R&D Systems Engineer

Pattern Bioscience is a clinical-stage startup developing an innovative product to improve medical care. We are tackling antibiotic resistance, one of the biggest public health challenges of our time. Our technology rapidly identifies bacterial infections and determines the most effective antibiotics for treatment. We are developing direct-from-specimen phenotypic rapid ID/AST assays using live cells on our proprietary instrument and consumable platform.

The Systems Engineer will be a critical member of the Hardware Engineering team, leading efforts as we transition our first product from development to production. You will work cross-functionally with design engineers, Assay Development, Software, Clinical Affairs, Quality, Regulatory, and Manufacturing to enhance product functionality, reliability, and manufacturability.

As a key member of an entrepreneurial startup team, this role is for you if you think big picture while also executing detailed plans, translating requirements and user needs into product improvements. You are proactive, knowing the next steps without being told. You enjoy hands-on work with the device and are particularly interested in the intersection of software and hardware engineering.

We are looking for a teammate, a problem solver—someone who is persistent, passionate, and driven to see projects through to completion.

• Lead the development of verification protocols and oversee testing alongside our software, mechanical, and electrical engineering teams.

• Analyze performance metrics across diagnostic devices to guide design improvements and refine manufacturing processes.

• Support and guide the qualification of diagnostic devices for clinical evaluations.

• Plan, coordinate, execute, and document verification and validation testing in collaboration with software, electrical, and mechanical engineering teams.

• Track and analyze performance data across prototype and production systems to prioritize reliability improvement efforts.

• Maintain and update risk and hazard analysis documentation, including Failure Modes and Effects Analysis (FMEA).

• Develop system requirements for current and future products by integrating user needs, technology capabilities, and engineering constraints.

• Manage engineering technician tasks related to performance, verification, and reliability testing.

• Formalize reporting for regulatory submissions.

• Are passionate about data-driven decision-making and using analysis to drive improvements.

• Have a strong understanding of design control and risk management practices.

• Apply statistical analysis and experimental design effectively in system engineering.

• Build strong relationships across disciplines and foster alignment among stakeholders.

• Think strategically, balancing compliance requirements with product feasibility.

• Persuade others by clearly contextualizing decisions and requirements.

• Enjoy solving system-level problems, working across disciplines to develop creative solutions and track down root causes.

• Communicate effectively across technical and non-technical audiences, both in writing and verbally.

• Successfully plan and manage multi-faceted projects, ensuring quality and timely execution.

• B.S. in Mechanical, Electrical, or Biomedical Engineering (M.S. preferred).

• 10+ years of industry experience in medical device or in-vitro diagnostic (IVD) product design and development, from concept through commercialization.

• Extensive experience with verification and validation phases of product development.

• Strong knowledge of FDA and industry standards, including ISO 13485, 21 CFR Part 820, ISO 14971, ISO 61010, and/or ISO 60601.

• Experience integrating complex medical device systems involving optical, electrical, thermal, mechanical, and software components.

• Proficiency in Python or an equivalent language for data manipulation and visualization.

• Experience with FMEA, SolidWorks, and/or optical or thermal system design is a plus.

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 an 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, disability status, protected veteran status, hair texture or protective hairstyle, or any other characteristic protected by law.