Senior NPI Optical Engineer

Madrona Venture Labs; San Carlos (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Madrona Venture Labs is seeking a Senior NPI Engineer specializing in optics to enhance our instrument operations team. This hands-on role involves optimizing manufacturing processes and ensuring product quality by collaborating with R&D.

The ideal candidate possesses a B.S. or M.S. in Engineering and has 5-7 years of experience in the medical device sector. Strong skills in optical principles and statistical process control are essential. Join us in making breakthrough innovations in biotech!

Qualifications

• 5–7 years of experience in a manufacturing or process engineering role, preferably in medical devices.
• Hands-on experience with statistical process control (SPC) and FMEA methodologies.
• Familiarity with quality management systems — ISO 13485, FDA QSR.

Responsibilities

• Partner with R&D on new product introductions ensuring smooth handoff to production.
• Design and optimize manufacturing processes for optical assemblies.
• Develop calibration procedures and maintain process documentation.

Skills

Optical principles

Statistical process control (SPC)

Problem-solving skills

Education

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

Tools

SolidWorks

Autocollimators

Spectrometers

Job description

Senior NPI Engineer – Optics

We are seeking a highly motivated hands‑on engineer with expertise in biotechnology hardware to join our instrument operations team. The 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
• Evaluate 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
• Assure product and process quality by designing testing methods
• Prepare product and process reports by collecting, analyzing, and summarizing information and trends
• Complete design and development projects by training and guiding technicians

Requirements

1. B.S. or M.S. in Mechanical Engineering, Optical Engineering, Manufacturing Engineering, or a related field
2. 5–7 years of experience in a manufacturing or process engineering role, preferably in medical devices, diagnostics, or life sciences instrumentation
3. Working knowledge of optical principles: geometric optics, alignment techniques, fiber coupling, interferometry, or spectroscopy preferred
4. Familiarity with optical alignment and characterization equipment (autocollimators, interferometers, optical power meters, spectrometers)
5. Experience with precision assembly techniques in cleanroom or controlled environments
6. Proficiency with GD&T, engineering drawings, and CAD tools (SolidWorks or equivalent)
7. Understanding of quality management systems — ISO 13485, FDA QSR, or GMP manufacturing environments
8. Hands‑on experience with statistical process control (SPC), DOE, and FMEA methodologies
9. 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