Manager, NPI Technical Operations

Position Overview

As Manager of NPI Technical Operations, you will drive process development, product transfer, and technical oversight for outsourced manufacturing of complex medical devices. In this role, you will partner with R&D, Quality, Supply Chain, and contract manufacturers to ensure production readiness, robust validations, and smooth scaling from pilot builds to commercial volumes.
Opportunity Highlights: Lead technical operations for a novel technology taking on the #1 killer in healthcare; shape manufacturing scale-up across external partners while influencing long‐term process strategy; and join a collaborative engineering environment where strong technical leadership drives product quality and reliability.

Key Responsibilities

• Lead technical aspects of new product transfer from R&D to contract manufacturing.
• Support scale-up from pilot to commercial production across external partners.
• Develop and maintain documentation including PFMEA, process flows, control plans, and IQ/OQ/PQ.
• Monitor yields, troubleshoot production issues, and drive corrective actions.
• Conduct performance reviews with contract manufacturers across quality, delivery, and cost.
• Execute COGS reduction initiatives through process optimization or supplier strategy.
• Support compliance with FDA, ISO 13485, and MDSAP requirements.
• Collaborate closely with R&D for design transfer and lifecycle support.

Required Qualifications

• Significant experience in medical device manufacturing, process development, or technical operations.
• Permanent authorization to work in the United States.
• Proven ability to manage outsourced manufacturing partners and execute product transfers.
• Strong understanding of catheter assembly, micro-mechanical processes, and electromechanical integration.
• Bachelor’s degree in Mechanical, Biomedical, Manufacturing Engineering, or related field.
• Hands-on experience with validation (IQ/OQ/PQ) and process documentation.
• Knowledge of FDA 21 CFR 820, ISO 13485, and international standards.
• Strong communication and cross‐functional collaboration skills.
• Ability to travel to supplier sites across North America.
• Work Authorization: Employer does not sponsor or assume sponsorship of employment visas.