NPI Buyer

About Kardion

Kardion is a medical device company developing advanced technologies intended to help improve patient outcomes. As the company expands its U.S. headquarters in Irvine and continues building its global operating model, it is hiring an NPI Buyer to support sourcing efforts for new medical device launches.

Role overview

The NPI Buyer owns sourcing strategy for new product development and launch programs. This position makes sure suppliers, materials, and services satisfy technical, commercial, and regulatory expectations across the full lifecycle, from early concept through commercialization. The role serves as a central connector between R&D, Quality, Operations, and suppliers to establish compliant, dependable, and cost-conscious supply chains for new product introductions.

Key responsibilities

• Develop sourcing plans for new product programs while staying aligned with supplier control requirements under FDA 21 CFR 820, ISO 13485, and EU MDR.
• Handle negotiations for development agreements, supply contracts, and pricing with strategic suppliers, ensuring the arrangements meet quality system and compliance expectations.
• Lead supplier identification, qualification, classification, and continuous assessment in line with ISO 13485:2016 and internal quality procedures.
• Find, evaluate, and onboard alternate suppliers to reduce supply risk and protect business continuity.
• Work closely with R&D, Engineering, Quality, and Program Management to ensure suppliers are ready from prototype stages through production handoff.
• Share supplier capabilities, emerging technologies, and regulatory needs with internal teams to support design-for-manufacturability and sourcing choices.
• Contribute to Design Control work by confirming supplier records, traceability, and material compliance align with FDA, ISO, and MDR expectations.
• Address supplier issues during development, including technical exceptions, quality concerns, and delivery delays.
• Monitor delivery timelines, handle inbound discrepancies, and coordinate expediting actions to avoid shortages.
• Look for opportunities to lower costs, improve lead times, and strengthen service performance across the NPI supply chain.
• Review project plans to identify logistics and regulatory documentation needs, including files required for DHF and DMR.
• Use delegated authority to approve purchase orders and payments where applicable.
• Support internal and external audits connected to supplier management, purchasing controls, and regulatory compliance.
• Maintain cost discipline and reduce material waste within the assigned scope.

Required qualifications

• Bachelor’s degree in Business Administration, Supply Chain, Engineering, or a related discipline.
• At least 5 years of experience in procurement or strategic sourcing within a global supply chain environment.
• Background purchasing components for medical devices or other regulated industries is strongly preferred.
• Working knowledge of FDA QSR, ISO 13485 supplier requirements, and EU MDR supplier documentation is a major plus.

Preferred qualifications

• Experience buying components for medical technology products and working with general contractors and subcontractors.
• Strong working knowledge of ERP systems such as SAP, Oracle, or similar procurement platforms.
• Ability to communicate clearly across engineering, quality, suppliers, and leadership, and to influence cross-functional partners.
• Proven success in negotiating complex supplier agreements and settling commercial disagreements.
• Capability to read technical drawings, specifications, and quality requirements.
• Fluency in English and German, with the ability to coordinate with Stuttgart-based operations and German-speaking suppliers.
• Collaborative, team-oriented approach in cross-functional environments.
• High standards of discretion, reliability, and professionalism when handling confidential supplier and product information.

Work environment and travel

This is a remote role within the United States, with the expectation of working across global time zones. Travel is estimated at 10% to 25% for visits to vendors and Kardion offices.

Compensation and benefits

The expected base pay for this position is $105,000 to $125,000 per year. Final compensation will depend on experience, qualifications, skills, and location. Kardion provides a benefits package that includes medical, dental, and vision coverage, a 401(k) plan, and paid time off.

Equal opportunity

Kardion is committed to equal employment opportunity and an inclusive workplace. Hiring decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.