Senior Consumable Development Engineer

Company: F. Hoffmann-La Roche Gruppe
Location: Carlsbad
Posted on: November 11, 2024

Job Description:

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionWe advance science so that we all have more time with the people we love.Roche is the world's #1 provider of companion diagnostics, offering unrivaled experience in developing and commercializing predictive tests that enable personalized treatment strategies for patients.The ideal candidate will have a solid understanding of physics and engineering fundamentals; and experience in designing fluidic consumable devices and developing consumable manufacturing processes, e.g., plastic injection molding, laser welding, ultrasonic welding, glue application, bead dispensing, heat shrink sealing and lyophilization. You will have experience in Design for Manufacturing (DFM) analysis for various manufacturing processes.Responsibilities

• You will design consumable fluidic devices for IVD assays.
• You will design and execute testing to characterize the functional performance of subassemblies.
• You will analyze data by applying statistical methods, summarize the results in reports and present to sub-team and/or project core team; drive troubleshooting, failure analysis, root cause investigation, issues closure and corrective action processes as required.
• You will design and build assembly/test jigs, fixtures and tools; you will develop and validate test methods and protocols (e.g., custom scripting, Gauge R&R) and execute validation testing (IQ/OQ/PQ).
• You will generate and release engineering drawings and documents including BOM, test reports, validation plans.
• You will interact with external vendors to plan and manage timelines and deliverables.This role is based on-site in Carlsbad, CA and Torrey Pines, CA. Relocation benefits are not being offered for this position.Who You Are:Required:
  • You have a BS with 5+ years of experience; or a MS with 3+ years of experience, or PhD with 1+ years in Engineering/Science with 5+ years of relevant industry experience.
  • You have demonstrated experience in designing and implementing IPQC methods and protocols, e.g., leak test, motor test, force test.
  • You have demonstrated proficiency (2+yrs) in CAD (Solidworks preferred).
  • You have demonstrated experience with design control under ISO standards.Preferred:
    • You have excellent written and verbal communication skills.
    • You have proficiency with Python, LabVIEW, or similar tools for device control and data acquisition.
    • You have proficiency with GD&T.
    • You have proficiency in JMP and Excel for data analysis.
    • You have proficiency with rapid prototyping technology such as 3D printers, laser cutters, CNC mills/lathes, etc.
    • You have proficiency with metrology equipment, e.g., force gauge, CMM/OMM, contact angle measurement, thickness measurement, optical profilometry, microscope.
    • You have a solid understanding of chemistry and biological assays.WORK ENVIRONMENTThe essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment. While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.This position is based on-site in Carlsbad, CA and Torrey Pines, CA. Relocation benefits are not available for this posting.The expected salary range for this position based in Carlsbad, CA / Torrey Pines, CA is $82,500 - $154,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.This position also qualifies for the benefits detailed at the link provided below..Who we areGenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark's ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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Keywords: F. Hoffmann-La Roche Gruppe, South Gate , Senior Consumable Development Engineer, Engineering , Carlsbad, California