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.

Position Summary
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.
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).

Other Responsibilities

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.

Required 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

This role is based in Irvine, California and follows a hybrid schedule with a strong emphasis on in office presence and some remote flexibility.
Willingness to work across global time zones.
Willingness to travel to global vendors and Kardion offices 10–25%.

Compensation
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.

Equal Employment Opportunity
Kardion is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.

About the company

Kardion is a medical technology company developing a catheter-based heart-support system. The company researches, engineers, tests, and prepares clinical and manufacturing programs for an implantable cardiovascular device. It serves clinicians, patients, researchers, regulators, clinical partners, and medical-device suppliers. Its operating model centers on device development coordinated across engineering, clinical, quality, regulatory, and manufacturing teams. Teams work across biomedical engineering, clinical affairs, quality, regulatory, manufacturing, research, and operations. Its work connects cardiovascular medical devices expertise with coordinated delivery for clinical and healthcare stakeholders.

Company Size

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Company Stage

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Total Funding

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Headquarters

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Founded

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Simplify's Take

What believers are saying

PICANTE enrolled in 2026 across Hartford and Christ Hospital, proving active clinical execution.
September 2026 trial pages describe an enrolling pivotal study, not a stalled prototype.
Patents published in March and August 2026 strengthen bargaining power with partners and acquirers.

What critics are saying

PICANTE results are due December 31, 2026; a miss blocks FDA and hospital adoption.
Kardion shows no disclosed funding, limiting manufacturing scale and trial expansion.
Impella’s incumbent network at Abiomed and Johnson & Johnson crushes weak clinical superiority claims.

What makes Kardion unique

Kardion’s CORY P4 targets high-risk PCI with randomized head-to-head evidence against Impella CP.
The company owns implantable vascular support patents filed in 2026, including flow-monitoring designs.
Steve Williamson became CEO in August 2026, signaling a commercialization-focused MedTech team.

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Benefits

Health Insurance
Dental Insurance
Vision Insurance

Company News

PR Newswire

Sep 22nd, 2026

Cadence Neuroscience appoints medtech executive Chris Cronin as CEO to lead clinical execution and platform growth.

Cadence Neuroscience appoints medtech executive Chris Cronin as CEO to lead clinical execution and platform growth. Cadence Neuroscience Sep 22, 2026, 09:00 ET Veteran medtech executive brings leadership experience across neuromodulation, clinical-stage company building, and commercialization; Founder Kent Leyde to lead technology and product development as CTO REDMOND, Wash., Sept. 22, 2026 /PRNewswire-PRWeb/ - Cadence Neuroscience, a clinical-stage company developing a biomarker-guided platform for personalized neuromodulation, announced the appointment of medtech executive Chris Cronin as Chief Executive Officer. Cronin joins as Cadence prepares for clinical evaluation of its investigational Biomarker Targeted Stimulation (BTS) system in focal drug-resistant epilepsy as its first indication, while building the capabilities to develop the platform across additional neurological conditions. Cronin brings nearly three decades of experience across medical technology, healthcare, finance, business development, and commercialization, including leadership experience in neuromodulation and other complex therapeutic-device categories. Kent Leyde, company founder, will become Chief Technology Officer and continue to lead Cadence's technology development, product strategy, and key external collaborations. Cronin most recently served as CEO and President of KARDION, a cardiovascular medical technology company, where he led the organization through a critical stage of growth as it moved from first-in-human to pivotal study. Previously, he held executive leadership roles at MOBĒ, helping scale the early-stage healthcare company, and spent more than a decade at Medtronic in leadership roles spanning cardiac and restorative therapies. As a Business Director at Medtronic, he held P&L responsibility across eight countries and regions for one of the company's largest franchises, with experience spanning neuromodulation modalities including deep brain stimulation, spinal cord stimulation, and intrathecal baclofen. Cadence's investigational BTS system is designed to use patient-specific neural biomarkers to inform stimulation and measure the brain's response to therapy. This biomarker-guided approach is intended to provide clinicians and researchers with real-time physiological feedback that may support more personalized and adaptable neuromodulation. Cadence is initially evaluating BTS in focal drug-resistant epilepsy, a serious condition in which many patients continue to experience seizures despite available anti-seizure medications and may have limited treatment options. This substantial unmet need makes focal drug-resistant epilepsy an important first indication for clinical evaluation of Cadence's platform. "Cadence has developed a fundamentally different approach to personalized neuromodulation - using patient-specific biomarkers not only to guide stimulation, but to measure how the brain responds," said Cronin. "The company has built a compelling technical and scientific foundation, and I'm excited to work with Kent, the board, clinical collaborators, and the broader team at this pivotal stage as we prepare for an important clinical study in focal drug-resistant epilepsy and build toward the broader potential of the Cadence platform across neurological conditions." "Chris' patient-centered approach to healthcare and medical devices is closely aligned with the way we've built Cadence from the beginning," said Leyde. "He brings deep business and medtech leadership experience at an important point in our growth. I'm pleased to have Chris leading the company while I focus on developing the technology and products at the heart of our work." "Cadence has reached an important inflection point," said Dan Moore, Independent Board Director at Cadence Neuroscience. "The company combines innovative technology with a clear initial clinical focus. Chris's experience in complex therapeutic-device categories and growth-stage medtech leadership complements Kent's continued technical leadership, positioning Cadence to execute its clinical plan and build toward future commercialization." Cadence's technology originated from research conducted by a Mayo Clinic Neurology and Neurosurgery team led by Gregory Worrell, M.D., Ph.D., a Mayo Clinic epileptologist and lead investigator. Cadence is building on this scientific foundation as it advances the BTS system through clinical evaluation. About Cadence Neuroscience Cadence Neuroscience is a clinical-stage medical technology company developing a biomarker-guided platform for personalized neuromodulation. Its investigational Biomarker Targeted Stimulation (BTS) system is designed to use patient-specific neural biomarkers to inform stimulation and measure the brain's response to therapy in real time. Cadence is initially advancing BTS in focal drug-resistant epilepsy, with a long-term goal of developing the platform for additional neurological conditions. Founded in 2017 and headquartered in Redmond, Washington, Cadence is building on technology originating from Mayo Clinic research. Cadence is backed by leading healthcare and technology investors, including F-Prime Capital, Jazz Venture Partners, LivaNova, Angelini Lumira Biosciences Fund, and Mayo Clinic. For more information, visit cadenceneuro.com. Mayo Clinic and Dr. Worrell have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research. Cadence Neuroscience is developing investigational medical technologies that have not been approved or cleared by the U.S. Food and Drug Administration (FDA) or other health authorities. Any forward-looking statements reflect current expectations and are subject to risks and uncertainties. Actual results may differ materially. This information is for educational purposes only and does not constitute medical advice or investigational device promotion. Patients should consult qualified healthcare providers regarding diagnosis and treatment options. Currently, these investigational technologies are only accessible through participation in a clinical trial. To learn more about these investigational technologies and how to access them, talk with your qualified healthcare provider or visit www.clinicaltrials.gov. Media Contact Alysa Wood, Cadence Neuroscience, 1 (425) 298-3184, [email protected], https://cadenceneuro.com/ SOURCE Cadence Neuroscience

Kardion

NPI Buyer

About the job