Senior NPI Optical Engineer
Nautilus Biotechnology
June 24, 2026
On-site
San Carlos, CA
$145,000 - $196,000 USD yearly
Operations
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 (lens systems, illumination modules, laser subsystems, camera integrations)
- Test, calibrate, and align optical modules, camera systems, and laser components to meet specifications and production tolerances
- Develop and maintain calibration procedures, alignment protocols, and acceptance criteria
- Establish and maintain process documentation (SOPs, work instructions, traveler sheets, control plans)
- Develop and implement fixtures, tooling, and automated assembly aids to improve yield, repeatability, and throughput
- Qualify new manufacturing processes/equipment; write and execute IQ/OQ/PQ protocols (ISO 13485 or FDA 21 CFR Part 820)
- Evaluate manufacturing processes using production failure modes/effect analysis
- Support supplier qualification and incoming inspection criteria for optical components
- Assure product/process quality by designing testing methods
- Prepare product and process reports by analyzing trends
- Train and guide technicians to complete design/development projects
Requirements:
- B.S. or M.S. in Mechanical Engineering, Optical Engineering, Manufacturing Engineering, or related field
- 5–7 years in manufacturing/process engineering (medical devices, diagnostics, or life sciences instrumentation preferred)
- Working knowledge of optical principles (geometric optics, alignment, fiber coupling, interferometry, spectroscopy)
- Familiarity with optical alignment/characterization equipment (autocollimators, interferometers, optical power meters, spectrometers)
- Precision assembly experience in cleanroom/controlled environments
- Proficiency with GD&T, engineering drawings, and CAD (SolidWorks or equivalent)
- Understanding of quality systems (ISO 13485, FDA QSR, or GMP)
- Hands-on SPC, DOE, and FMEA
- Data-driven problem-solving skills
Preferred qualifications:
- Experience with fluorescence-based imaging, flow cytometry, PCR instrumentation, or similar biotech platforms
- Familiarity with AOI or machine vision systems
- Six Sigma Green Belt/Black Belt
- Familiarity with Arena and NetSuite
- 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 (lens systems, illumination modules, laser subsystems, camera integrations)
- Test, calibrate, and align optical modules, camera systems, and laser components to meet specifications and production tolerances
- Develop and maintain calibration procedures, alignment protocols, and acceptance criteria
- Establish and maintain process documentation (SOPs, work instructions, traveler sheets, control plans)
- Develop and implement fixtures, tooling, and automated assembly aids to improve yield, repeatability, and throughput
- Qualify new manufacturing processes/equipment; write and execute IQ/OQ/PQ protocols (ISO 13485 or FDA 21 CFR Part 820)
- Evaluate manufacturing processes using production failure modes/effect analysis
- Support supplier qualification and incoming inspection criteria for optical components
- Assure product/process quality by designing testing methods
- Prepare product and process reports by analyzing trends
- Train and guide technicians to complete design/development projects
Requirements:
- B.S. or M.S. in Mechanical Engineering, Optical Engineering, Manufacturing Engineering, or related field
- 5–7 years in manufacturing/process engineering (medical devices, diagnostics, or life sciences instrumentation preferred)
- Working knowledge of optical principles (geometric optics, alignment, fiber coupling, interferometry, spectroscopy)
- Familiarity with optical alignment/characterization equipment (autocollimators, interferometers, optical power meters, spectrometers)
- Precision assembly experience in cleanroom/controlled environments
- Proficiency with GD&T, engineering drawings, and CAD (SolidWorks or equivalent)
- Understanding of quality systems (ISO 13485, FDA QSR, or GMP)
- Hands-on SPC, DOE, and FMEA
- Data-driven problem-solving skills
Preferred qualifications:
- Experience with fluorescence-based imaging, flow cytometry, PCR instrumentation, or similar biotech platforms
- Familiarity with AOI or machine vision systems
- Six Sigma Green Belt/Black Belt
- Familiarity with Arena and NetSuite