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. How You’ll Make an Impact 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. Your Contributions 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. We’d Love to Hear from You If You 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. Desired Education & Experience 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. 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 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.        

Senior Manager, IVD Assay Manufacturing     About Pattern Bioscience   Pattern Bioscience is a fast-growing, clinical-stage startup tackling one of the biggest public health challenges of our time: antibiotic resistance. Using machine learning and microfluidics, we rapidly identify the bacteria causing infections and predict the most effective treatments.     The Role   We are seeking a strategic, collaborative, and entrepreneurial Senior Manager, IVD Assay Manufacturing to lead and scale a compliant consumable manufacturing operation for our high-resolution In Vitro Diagnostic (IVD) medical device. This role is critical in driving our production capabilities forward as we prepare for clinical trials and commercialization. If you're looking for an opportunity to make a significant impact in a startup environment while expanding your leadership skills and growing your career, we’d love to hear from you.     Key Responsibilities   Develop and execute production plans to meet product development and clinical trial needs.   Monitor and report on process excellence metrics to ensure efficiency and quality.   Define and implement effective design transfer requirements for new product introduction and changes.   Drive continuous improvement initiatives in quality, compliance, safety, efficiency, and scalability.   Optimize critical process parameters and ensure robust process control.   Manage consumable-related BOMs, resource routings, lot size standards, and cost variances.   Oversee maintenance of equipment and tools to ensure reliability and productivity.   Lead validation activities for equipment, processes, and test methods.   Build and develop a high-performing team aligned with organizational values.   Address audit findings, non-conformances, and process improvement opportunities.   Drive infrastructure enhancements and departmental budgeting processes.   Promote a culture of safety, compliance, and operational excellence.   Six-Month Goals   Implement NetSuite integrations with Arena PLM.   Enhance electronic production execution systems.   Establish critical business processes for clinical trial success.   Deliver value stream mapping and targeted process improvements.   Develop process validation plans, PFMEAs, and validation strategies for clinical trial readiness.   Expand manufacturing capacity and establish requirements for future facilities.   Recruit and onboard key hires to support clinical trial objectives.   Define and implement process excellence KPIs and reporting standards.   Requirements  Strong understanding of FDA regulations related to IVD medical device production (21 CFR 820, ISO 13485).   Experience with cleanroom operations and formulation of high-complexity reagents.   Expertise in Lean Manufacturing, Process Failure Mode and Effects Analysis (PFMEA).   Proven ability to foster a safety-focused culture.   Skilled in engineering change management and cost accounting principles.   Analytical problem solver with a passion for continuous improvement.   Clear and effective communicator, including strong technical writing skills.   Experienced people manager who values team development and cross-functional collaboration.   Qualifications   B.S. in a technical or life sciences-related field.   Minimum 7 years of experience in biotech or medical device manufacturing.   At least 5 years in a leadership or management role.   Experience with lyophilization and/or BSL-2 environments is a plus.   Why Join Us?   We are building world-changing technology, and we need passionate individuals to help us succeed. At Pattern Bioscience, you’ll work alongside a top-tier, multi-disciplinary team in a culture that values innovation, learning, and adaptability. We offer:   Health insurance.   401(k) matching.   Paid time off.   The opportunity to make a global impact.   We celebrate diversity and are committed to fostering an inclusive environment. All qualified applicants will receive consideration for employment regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.