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
