Optikos
Wakefield, MA, USA
Job Type Full-time Description Optikos is seeking a New Product Introduction (NPI) Engineer to join our manufacturing team. In this key role, you will work closely with customers and internal teams-including optical and mechanical design, quality, supply chain, and manufacturing-to prepare novel optical systems for production. This includes both initial builds and full manufacturing ramp-up for internally developed products and customer-supplied designs. A strong background in medical device manufacturing and a working knowledge of ISO 13485 are essential. Projects span industries such as medical diagnostics, defense, and virtual reality. Responsibilities: Lead the transfer of optical systems and medical device subassemblies from design-internal or customer-supplied-into manufacturing readiness. Develop and execute NPI project plans, including timelines, process development, risk assessments (FMEA), quality requirements (IQ/OQ/PQ), documentation and resource coordination....