NPI Buyer

Summary

Location
:
Irvine, CA
Travel
: 10-25%
About Kardion
Kardion is a medical device company advancing innovative technology to improve patient outcomes. As we continue to scale our U.S. headquarters in Irvine and strengthen our global operating model, we are seeking an NPI Buyer to drive sourcing strategies that support the design, development, and successful launch of new medical device products.

The NPI Buyer is responsible for developing and executing sourcing strategies that support the design, development, and launch of new medical device products. This role ensures that suppliers, materials, and services meet all technical, commercial, and regulatory requirements, including FDA QSR, ISO 13485, and EU MDR, from concept through commercialization.

The NPI Buyer acts as a key interface between R&D, Quality, Operations, and external suppliers to secure compliant, cost-effective, and reliable supply chains for new product introductions.

• Lead sourcing strategy for new product development, ensuring alignment with FDA 21 CFR 820, ISO 13485, and EU MDR supplier control requirements.
• Negotiate complex development agreements, commercial supply contracts, and pricing with strategic suppliers, ensuring compliance with regulatory and quality system expectations.
• Drive supplier selection, qualification, categorization, and ongoing evaluation in accordance with ISO 13485:2016 and internal QMS procedures.
• Identify, assess, and onboard second‑source suppliers to mitigate supply chain risk and ensure business continuity.
• Collaborate closely with R&D, Engineering, Quality, and Program Management to ensure supplier readiness from prototype through production transfer.
• Communicate supplier capabilities, new technologies, and regulatory requirements to internal stakeholders to support design‑for‑manufacturability and sourcing decisions.
• Support Design Control activities by ensuring supplier documentation, traceability, and material compliance meet FDA, ISO, and MDR expectations.
• Resolve supplier‑related issues during development projects, including technical deviations, quality concerns, and delivery challenges.
• Track delivery schedules, manage inbound discrepancies, and coordinate with suppliers to expedite shipments and prevent shortages.
• Identify opportunities for cost reduction, lead‑time optimization, and service improvements across the NPI supply chain.
• Review project plans to clarify logistical and regulatory requirements, including documentation needed for Design History File (DHF) and Device Master Record (DMR).

• Maintain cost discipline and minimize material waste within the scope of responsibility.
• Exercise signature authority for purchase orders and payments as delegated.
• Support internal and external audits related to supplier management, purchasing controls, and regulatory compliance.

• Bachelor’s degree in Business Administration, Supply Chain, Engineering, or related field.
• Minimum 5 years of procurement or strategic sourcing experience in a global supply chain environment.
• Experience purchasing components for medical devices or other regulated industries strongly preferred.
• Familiarity with FDA QSR (21 CFR 820.50 – Purchasing Controls), ISO 13485 supplier requirements, and EU MDR supplier documentation expectations is a significant advantage.

• Prior experience purchasing components for medical technology products and contracting with general contractors and subcontractors.
• Demonstrated proficiency with ERP systems (SAP, Oracle, or equivalent platforms) and procurement workflows.
• Proven ability to communicate technical and commercial concepts clearly to diverse audiences (engineering, quality, suppliers, leadership) and influence cross‑functional teams.
• Track record of successfully negotiating complex supplier agreements and resolving commercial disputes.
• Ability to interpret technical drawings, specifications, and quality requirements.
• Fluency in both English and German, with the ability to coordinate with Stuttgart-based operations and German‑speaking suppliers.
• Strong team orientation in collaborative, cross-functional…