Senior NPI Optical Engineer

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
• 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 effects 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

Qualifications

• 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
• Familiarity with optical principles: geometric optics, alignment techniques, fiber coupling, interferometry, or spectroscopy preferred
• 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