Which medical device roles do you place?

Plant Directors and General Managers, VPs of Manufacturing and Operations, Quality and Regulatory Directors under ISO 13485 / 21 CFR Part 820 / MDR, R&D and Design Assurance leaders, Supply Chain Directors, and Country Managers Mexico for regulated operations.

How do you assess regulatory depth?

The Dynamic Fit Method™ tests real command of design controls, CAPA, complaint handling, and audit readiness — not just certification names. Silvia's engineering and quality background is a natural fit for the depth these roles demand.

Industry · Medical Device Manufacturing

Medical Device Manufacturing Executive Search

Manufacturing, quality, regulatory, and operations leadership for medical-device OEMs and contract manufacturers across the US–Mexico corridor.

Silvia Flores leads medical devices executive search across the US–Mexico corridor — with a strong footprint in Baja California, Sonora, Chihuahua, Nuevo León, and Jalisco, connected to US medical clusters in California, Minnesota, Massachusetts, and Indiana. The practice serves OEMs, contract manufacturers, and Tier suppliers operating under ISO 13485, FDA 21 CFR Part 820, and MDR.

Segments served

Class I, II, and III device manufacturers
Contract manufacturers (CMOs / CDMOs) and OEM partners
Diagnostics, imaging, and surgical instruments
Cardiovascular, orthopedic, and interventional devices
Sterile packaging, cleanroom operations, and molding
ISO 13485, FDA 21 CFR Part 820, and MDR compliance
Design controls, CAPA, and post-market surveillance

The roles

Plant Directors and General Managers; VPs of Manufacturing and Operations; Quality and Regulatory Directors; R&D and Design Assurance leaders; Supply Chain and Materials Directors; Country Managers for Mexico operations; and Commercial Directors serving hospitals, IDNs, and OEM partners.

How the search runs

Through The Dynamic Fit Method™ — Ability, Capability, Capacity — delivered via Alder Koten. Connects to the manufacturing, quality, and supply chain practices.

Medical devices search — questions

Which medical device roles do you place?: Plant Directors and General Managers, VPs of Manufacturing and Operations, Quality and Regulatory Directors under ISO 13485 / 21 CFR Part 820 / MDR, R&D and Design Assurance leaders, Supply Chain Directors, and Country Managers Mexico for regulated operations.
Where in Mexico does the medical-device cluster sit?: Baja California (Tijuana, Mexicali, Ensenada) leads, followed by Sonora, Chihuahua, Nuevo León, and Jalisco — connected to US medical corridors in California, Minnesota, Massachusetts, and Indiana.
How do you assess regulatory depth?: The Dynamic Fit Method™ tests real command of design controls, CAPA, complaint handling, and audit readiness — not just certification names. Silvia's engineering and quality background is a natural fit for the depth these roles demand.