Mechanical Engineer NPI Instrumentation Yoh

K-Tek Resourcing LLC

Verified

14h agoBoston, Massachusettscontract

Own the New Product Introduction (NPI) process for transition into manufacturing at a Boston-based medical device company. Design and build fixtures for sub-component testing, then develop and implement operational methods for sub-assembly production. Collaborate with cross-functional teams to drive continuous improvement and 8D problem solving. This role cuts production labor and material costs while improving efficiency and utilization. You'll work with NPI, 8D, and CAD tools in a fast-paced contract environment.

You will lead end-to-end product transitions from development to scalable, compliant manufacturing at a global medical device manufacturer. You will own the NPI strategy, cross-functional execution with R&D, Quality, Regulatory, and Operations, and build resilient systems for volatile regulatory and supply chain conditions. This role blends strategic leadership with operational rigor, demanding expertise in FDA regulations, ISO 13485, and design controls. You will drive rapid launches while maintaining safety and compliance, and build a high-performing team capable of thriving under uncertainty.

You will own the manufacturing process workstream for One Stop Systems' rugged AI and edge compute products, transitioning designs into scalable production for defense and commercial customers. Reporting to the VP of Operations, you'll partner with Engineering, Quality, and external manufacturers in a high-mix, low-volume environment. This role combines hands-on root-cause problem solving with data-driven Lean improvements across assembly, test, and inspection. You'll drive design-for-manufacturability feedback, build documentation, and lead NPI readiness, making a direct impact on product quality and throughput.

Join the R&D team at Globus Medical to own mechanical design for intraoperative neuromonitoring systems used in complex spinal and cranial surgeries. You will lead both sustaining and next-generation NPI projects from concept through commercialization, collaborating with Regulatory, Quality, Supply Chain, and Manufacturing. Work directly with surgeons and OR staff to translate clinical needs into tangible solutions. This role offers the chance to shape products that improve patient outcomes and drive innovation in a fast-paced medical device environment.

You will own manufacturing processes for high-precision parts in semiconductor, medical devices, and advanced tech hardware, with tolerances measured in microns. You will drive new product introductions (NPI) and continuous improvement across CNC milling, turning, and finishing operations. You will work with a passionate team using top-of-the-line equipment, solving daily production issues and optimizing efficiency. This role stands out for its direct impact on complex, high-stakes components in a shop where craftsmanship matters.

You will own complete technical integration of complex pharmaceutical manufacturing equipment, from installation through qualification. This role centers on system-level engineering for two aseptic filling systems at a major pharmaceutical customer. You will lead IQ/OQ qualification activities, coordinate mechanical, controls, automation, and validation teams, and translate regulatory requirements into system specs. With direct exposure to customers and engineering leadership, you will influence system architecture and technical strategy for GMP-regulated environments. This position offers a clear path to Principal Engineer or Technical Leadership roles, supporting life-saving products.