Senior NPI Optical Engineer

Nautilus Biotechnology; San Carlos (CA); On-site; USD 145,000 - 196,000; Full time

Job summary

Nautilus Biotechnology seeks a Senior NPI Engineer – Optics to join our instrument operations team, scaling production of our proteomics platform and partnering with R&D, supply chain, and contract manufacturers to ensure high quality and efficient manufacturing.

The role requires 5–7 years in manufacturing or process engineering, strong optical knowledge, and hands-on experience with precision assembly in cleanrooms.

Qualifications

• B.S. or M.S. in Mechanical, Optical, or Manufacturing Engineering.
• 5–7 years in manufacturing or process engineering, preferably in medical devices or life sciences.
• Strong knowledge of optical principles and alignment techniques.
• Experience with precision assembly in cleanrooms.
• Proficiency with GD&T, drawings, and CAD (SolidWorks).
• Familiarity with ISO 13485 / FDA QSR / GMP environments.
• Hands-on SPC, DOE, and FMEA methodologies.
• Data-driven problem solving.

Responsibilities

• Partner with R&D on NPI transfers to production.
• Design and optimize manufacturing processes for optical assemblies and camera integrations.
• Test, calibrate, and align optical modules to meet specs.
• Develop calibration procedures and acceptance criteria.
• Maintain SOPs, traveler sheets, and control plans.
• Develop fixtures and automation to improve yield and throughput.
• Qualify new processes and write IQ/OQ/PQ protocols per ISO/FDA.
• Evaluate processes via FMEA.
• Support supplier qualification and incoming inspection of optics.
• Ensure product and process quality with testing methods.
• Compile reports on trends and performance.
• Train and guide technicians on designs and processes.

Skills

Optical engineering

NPI

Manufacturing process design

GD&T

Cleanroom assembly

Statistical methods

Problem solving

Education

B.S. or M.S. in Mechanical Engineering, Optical Engineering, or Manufacturing Engineering

Tools

SolidWorks

Arena

NetSuite

Interferometers

Spectrometers

Job description

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.

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 process reports by collecting, analyzing, and summarizing information and trends.
• Completes design and development projects by training and guiding technicians.

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

Preferred Qualifications

• 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

Nautilus Team Culture

• We are determined to do whatever it takes to get our platform into the hands of researchers who will use it to upend the status quo in basic research and healthcare.
• We work on cross functional teams, wear many hats, take risks to work through uncertainty, enjoy working collaboratively on challenging problems, and celebrate one another’s victories.
• We go above and beyond, but also strive to provide a supportive atmosphere of colleagues who are willing to lend a helping hand and make working at Nautilus not only fulfilling in its end goals, but enjoyable on a day-to-day basis.

Our Values:

• Be Excellent
• Be a Good Human
• Catalyze Customer Success
• Dream Big
• Drive for Results
• Enjoy the Voyage
• Succeed as One Team

Compensation Range: $145K - $196K