NPI Buyer

Responsibilities

• 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).

Qualifications

• 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.

Preferred Qualifications

• 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 environments.
• High level of discretion, reliability, and professional integrity in managing confidential supplier and product information.

Work Environment/Travel

• Remote (US), with willingness to work across global time zones.
• Willingness to travel to global vendors and Kardion offices 10–25%.

Pay

The anticipated base salary range for this position is $105,000 – $125,000 annually. Actual compensation will be determined based on experience, qualifications, skills, and location. Kardion offers a comprehensive benefits package including medical, dental, and vision coverage, 401(k), and paid time off.