Senior NPI Optical Engineer

Nautilus BiotechnologySan Carlos, CA
$145,000 - $196,000

About The Position

At Nautilus, we have a big and important mission: improve the health of millions by unleashing the potential of the proteome to accelerate drug development and enable a new world of precision and personalized medicine. We are developing a single-molecule protein analysis platform of unprecedented sensitivity, scale, and ease of use that we believe will democratize access to the proteome – one of the most dynamic and valuable sources of biological insight. To accomplish this, we are pursuing deep, hard science with an entrepreneurial mindset and creating a world-class team of builders, innovators, and dreamers across a wide range of disciplines. We are seeking a highly motivated hands on Senior NPI Engineer – Optics with expertise in biotechnology hardware to join our instrument operations team. The ideal candidate will play a key role in scaling and optimizing the production of our proteomics platform. The candidate will collaborate with R&D, supply chain and contract manufacturing to ensure the highest product quality and most efficient production. This role involves transferring subassembly designs from R&D, developing and refining manufacturing processes, troubleshooting hardware issues, and driving continuous improvements in production efficiency and reliability.

Requirements

  • B.S. or M.S. in Mechanical Engineering, Optical Engineering, Manufacturing Engineering, or a related field
  • 5–7 years of experience in a manufacturing or process engineering role, preferably in medical devices, diagnostics, or life sciences instrumentation
  • Working knowledge of optical principles: geometric optics, alignment techniques, fiber coupling, interferometry, or spectroscopy preferred
  • Familiarity with optical alignment and characterization equipment (autocollimators, interferometers, optical power meters, spectrometers)
  • Experience with precision assembly techniques in cleanroom or controlled environments
  • Proficiency with GD&T, engineering drawings, and CAD tools (SolidWorks or equivalent)
  • Understanding of quality management systems — ISO 13485, FDA QSR, or GMP manufacturing environments
  • Hands-on experience with statistical process control (SPC), DOE, and FMEA methodologies
  • Strong problem-solving skills with a bias toward data-driven decision-making

Nice To Haves

  • Experience with fluorescence-based imaging, flow cytometry, PCR instrumentation, or similar biotech platforms
  • Familiarity with automated optical inspection (AOI) or machine vision systems
  • Six Sigma Green Belt or Black Belt certification
  • Familiarity with Arena and NetSuite

Responsibilities

  • Partner with R&D on new product introductions (NPI), ensuring smooth handoff from development to production
  • Design, develop, and optimize manufacturing processes for optical assemblies, including lens systems, illumination modules, laser subsystems, and camera integrations used in biotech instrumentation
  • Test, calibrate, and align optical modules, camera systems, and laser components to ensure performance meets design specifications and production tolerances
  • Develop and maintain calibration procedures, alignment protocols, and acceptance criteria for optical and laser subsystems
  • Establish and maintain process documentation including SOPs, work instructions, traveler sheets, and control plans
  • Develop and implement fixtures, tooling, and automated assembly aids to improve yield, repeatability, and throughput
  • Proficiency in design for manufacturability and reliability.
  • Qualify new manufacturing processes and equipment; write and execute IQ/OQ/PQ protocols in compliance with ISO 13485 or FDA 21 CFR Part 820 requirements
  • Evaluates manufacturing processes by designing and conducting production failure modes and effect analysis
  • Support supplier qualification and incoming inspection criteria for optical components such as mirrors, prisms, filters, fiber optics, and coated optics
  • Assures product and process quality by designing testing methods.
  • Prepares product and reports by collecting, analyzing, and summarizing information and trends.
  • Completes design and development projects by training and guiding technicians.
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