New Product Introduction Engineer : 1st Generation Surgical Robotic Technology

Job Description

Senior NPI Engineer : Components

Dedham, MA / Onsite Position

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 assited 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

Preferred