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Position Overview: As Head of Operations and Manufacturing, you’ll lead the development of PSYONIC’s production systems, manage and grow our manufacturing capabilities, and serve as the operational backbone of the company as we scale. This is a build-and-own role—ideal for someone who thrives in early-stage environments and knows how to scale hardware production without compromising quality or speed.

Key Responsibilities:

• Manufacturing & Production

  • Scale production from 300 to 1,000 units in 6 months

  • Build and refine workstations, assembly line layouts, and tooling strategies

  • Improve throughput using lean manufacturing, 5S, and Six Sigma principles

  • Track and drive down cycle time, rework rates, and cost of goods sold (COGS)

• Operations Strategy & Execution

  • Design and implement scalable systems across procurement, inventory, and fulfillment

  • Collaborate with Engineering, Design & Brand, and Sales Support departments to align production with demand

  • Maintain strong process documentation and ensure team accountability

  • Develop KPIs and dashboards for real-time operational insights

• Supply Chain & Vendor Management

  • Optimize sourcing and vendor performance (cost, quality, lead time)

  • Ensure continuity in supply through vendor diversification and forecasting

  • Oversee inventory management, JIT systems, and material flows

• Team Development & Leadership

  • Lead and mentor the operations and manufacturing team, including existing Director of Operations

  • Set clear expectations, delegate effectively, and develop internal team capabilities

  • Foster a culture of ownership, continuous improvement, and mission alignment

• Quality & Compliance

  • Work closely with Regulatory to establish and maintain ISO 13485 and FDA compliance

  • Oversee implementation of QA/QC processes and internal audits

Qualifications:

• 7+ years in operations, manufacturing, or supply chain roles (hardware, medtech, robotics preferred)

• Proven track record scaling production from low-volume to 1,000+ units/year

• Deep fluency in lean, Six Sigma, and production metrics (yield, throughput, OEE)

• Experience managing multidisciplinary teams and cross-functional initiatives

• Familiarity with ERP systems and modern operations tools (e.g., Hubspot, Katana, MRP/ERP)

• Bonus: Background in robotics, prostheses, medical devices, or FDA-regulated environments