NPI Buyer
reputed company Location: Remote Travel: 10-25% About reputed company reputed company is a medical device company advancing innovative technology to improve patient reputed company. As we continue to reputed company our U.S. reputed company 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. Position reputed company 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 reputed company technical, reputed company, and regulatory requirements, including FDA QSR, ISO 13485, and EU MDR, from concept through commercialization. The NPI Buyer acts as a key reputed company between R&D, reputed company, Operations, and external suppliers to secure compliant, cost-effective, and reliable supply chains for new product introductions. Responsibilities
- reputed company sourcing reputed company for new product development, ensuring alignment with FDA 21 CFR 820, ISO 13485, and EU MDR supplier control requirements.
- Negotiate reputed company development agreements, reputed company supply reputed company, and pricing with strategic suppliers, ensuring compliance with regulatory and reputed company system expectations.
- Drive supplier selection, qualification, categorization, and ongoing evaluation in accordance with ISO 13485:2016 and internal QMS procedures.
- Identify, assess, and reputed company second‑reputed company suppliers to mitigate supply chain risk and ensure business continuity.
- Collaborate closely with R&D, Engineering, reputed company, 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 reputed company.
- Support Design Control activities by ensuring supplier documentation, traceability, and material compliance meet FDA, ISO, and MDR expectations.
- Resolve supplier‑reputed company issues during development reputed company, including technical deviations, reputed company concerns, and delivery challenges.
- reputed company delivery schedules, manage inbound discrepancies, and coordinate with suppliers to expedite shipments and prevent shortages.
- Identify opportunities for cost reduction, reputed company‑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 reputed company the scope of responsibility.
- Exercise signature authority for purchase orders and payments as delegated.
- Support reputed company audits reputed company to supplier management, purchasing controls, and regulatory compliance.
- Bachelor’s degree in Business Administration, Supply Chain, Engineering, or reputed company 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 (reputed company, reputed company, or equivalent platforms) and procurement workflows.
- Proven ability to communicate technical and reputed company concepts reputed company to diverse audiences (engineering, reputed company, suppliers, leadership) and influence cross-functional teams.
- reputed company record of successfully negotiating reputed company supplier agreements and resolving reputed company disputes.
- Ability to interpret technical drawings, specifications, and reputed company requirements.
- reputed company in both English and German, with the ability to coordinate with Stuttgart-based operations and German-speaking suppliers.
- Strong team orientation in reputed company, cross-functional environments.
- High level of discretion, reliability, and reputed company reputed company in managing confidential supplier and product information
- Remote (US), with willingness to work across global time zones.
- Willingness to travel to global vendors and reputed company offices 10–25%.
Compensation The anticipated reputed company salary reputed company for this position is $105,000 – $125,000 annually. Actual compensation will be determined based on experience, qualifications, skills, and location. reputed company offers a comprehensive benefits package including medical, dental, and reputed company coverage, 401(k), and reputed company time off. Equal Employment Opportunity reputed company is an equal opportunity employer. We are committed to creating an inclusive environment for reputed company and do not discriminate on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, age, disability, veteran status, or any other protected characteristic under applicable law.
Originally posted on Himalayas
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