New Product Introduction Engineer

New Product Introduction Engineer : 1st Generation Surgical Robotic Technology Medical Device / Surgical Robotic Technology PE Backed 1st Generation Build Our client is a stealth-mode Boston area medical robotics start-up developing a first-generation medical capx platform capable of disrupting current standard of robotic assisted diagnostic and therapeutic procedures. We are seeking a dynamic and experienced NPI Manufacturing Engineer to lead the development, scaling, and implementation of pilot manufacturing and commercial production strategies for our client's breakthrough medical robotic platform. This new key executive leader will spearhead all manufacturing architecture and strategy guiding this 1st of its kind medical robotic concept from prototype through advanced pilot manufacturing process design, quality assurance, supply chain management, onward through commercial‑scale global production. Key Responsibilities Serve as a technical lead in transferring devices from design/prototype to production, ensuring accurate translation of design outputs into scalable manufacturing processes Act as component technical expert—select, evaluate, and suggest alternatives Work with internal and external partners to plan, design, develop, qualify, validate, and stabilize component and equipment development process solutions for New Product Development (NPD) projects. Act as the liaison between the Operations, R&D, and Quality teams as well as component & equipment suppliers Provide "voice of manufacturing" to ensure product/equipment designs incorporate DFM/A principals and/or Lean Six Sigma/DMAIC/DMADV process knowledge. Support prototype development and testing, TMD, TMV and Fixture design. Transfer devices and processes from R&D to manufacturing including verification and validation activities Maintain documentation: design control, risk management, technical records for regulatory submissions Develop manufacturing processes and creation of Device Master Records (DMRs). Support DFMEA, PFMEA, Control Plans, root‑cause analyses, DOE, SPC Define, write, and execute IQ/OQ/PQ protocols to verify equipment/process capability Collaborate with manufacturing, QA, clinical, and regulatory teams (FDA, ISO, EU MDR) Prepare BOMs, Identify required equipment, fixtures, tools; work with suppliers and vendors to verify quality Required Qualifications Bachelor’s or master’s in Biomedical, Mechanical, or related engineering and 5 years industry experience Experience with CAD (SolidWorks) prototyping & testing Statistical Analysis knowledge (e.g., Design of Experiments (DOE), Process Stability/Control/Capability). Experience in Design for Manufacturing, Assembly and Service (DFM/DMA/)DFX Hands on fabrication experience in lab or machine shop environments Strong problem‑solving, documentation, multi‑project management skills Experience with Verification and Validation of devices and processes (IQ/OQ/PQ, gage R&R, and similar) Knowledge of regulatory frameworks: ISO 13485, FDA QSR (21 CFR 820), and possibly ISO 14971/10993 Preferred Advanced Degree Familiarity with materials for medical devices Experience working in a highly regulated industry, preferably medical devices Familiarity with component selection, risk management (FMEA), statistical tools Process Excellence Six Sigma knowledge or certification Ability to collaborate with cross‑functional teams, vendors, suppliers Knowledgeable about medical‑specific assembly technologies, the equipment supplier base, and the capabilities of the suppliers. Seniority level Mid‑Senior level Employment type Full‑time Job function Manufacturing, Engineering, and Project Management Industries: Medical Equipment Manufacturing, Robotics Engineering, and Biotechnology Research Location: Boston, MA #J-18808-Ljbffr