Manager, NPI Technical Operations

Job Description

Job DescriptionOpportunity Highlights

• Lead technical operations for a novel technology that's taking on the #1 killer in healthcare.
• Shape manufacturing scale-up across external partners while influencing long-term process strategy.
• Join a collaborative engineering environment where strong technical leadership drives product quality and reliability.

The Work You’ll Lead
As Manager of NPI Technical Operations, you will drive process development, product transfer, and technical oversight for outsourced manufacturing of complex medical devices. 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. This role combines hands-on engineering with cross-functional leadership to support high-quality, cost-effective manufacturing.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.

Requirements

• 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
This position requires permanent authorization to work in the United States. At this time, the employer is not able to sponsor or assume sponsorship of employment visas for this role.About MedTech Talent Solutions
MedTech Talent Solutions partners exclusively with medtech companies to connect exceptional talent with opportunities that shape the future of healthcare technology. We present a menu of recruiting solutions from which clients can choose, tailoring our approach to their unique needs. Our expertise is grounded in real-world experience, having served as internal recruiters inside some of the most demanding and highest-performing medtech companies. That insider perspective allows us to deliver with the precision, pace, and discretion the industry demands. Every application is reviewed by an experienced recruiter, and we treat each candidate’s goals with care and respect.Our mission is simple: to create matches that are successful, lasting, and meaningful — to candidates and, ultimately, to patients.Ready to Learn More?
Apply through this posting or connect with us directly. We will share additional details with qualified candidates after an initial conversation.