Director, Manufacturing Engineering & External Operations

KARDION; Irvine (CA); Hybrid; USD 200,000 - 220,000; Full time

Job summary

Kardion, Irvine, CA-based leader in cardiovascular medical devices, seeks a senior leader to build and scale Manufacturing Engineering & External Operations in a virtual manufacturing environment. You will drive industrialization, design transfer, and readiness for clinical and commercial launches in collaboration with R&D, Quality, Regulatory, Clinical, and Supply Chain.

Leadership focuses on process validation, governance, and supplier management across contract manufacturers.

Qualifications

• Bachelor's degree in Engineering or related field.
• 10+ years in Manufacturing Engineering, Industrialization, or Technical Operations within medical devices.
• Experience with Class III devices or complex interventional products.
• Proven leadership in outsourced manufacturing; supplier management and design transfer.
• Strong knowledge of FDA Design Controls, QSR/QMSR, ISO 13485, ISO 14971, and EU MDR.
• Fluent English; German advantageous.
• Willingness to travel up to 30% to Germany.

Responsibilities

• Lead and scale Manufacturing Engineering & External Operations in a virtual environment.
• Oversee manufacturing industrialization, design transfer, and commercialization readiness for Class III devices.
• Drive DFM, scalability, and technical transfer with R&D and external partners.
• Manage contract manufacturers and suppliers; ensure validation and process capability.
• Establish governance, KPIs, validation strategies, and supplier performance management.
• Collaborate with Quality, Regulatory, Clinical, and Supply Chain on submissions and CAPA.
• Drive continuous improvement across external manufacturing network for yield and cost efficiency.
• Support capacity planning and long-term scale-up with business growth.

Skills

Manufacturing engineering

Industrialization

Supplier management

Design transfer

Process validation IQ/OQ/PQ

Regulatory knowledge (FDA QSR/QMSR)

Leadership

English fluency

Education

Bachelor’s degree in Engineering or related field

Tools

PFMEA

IQ/OQ/PQ protocols

FDA Design Controls

ISO 13485

EU MDR

Job description

Kardion, Irvine, CA-based leader in cardiovascular medical devices, seeks a senior leader to build and scale Manufacturing Engineering & External Operations in a virtual manufacturing environment. You will drive industrialization, design transfer, and readiness for clinical and commercial launches in collaboration with R&D, Quality, Regulatory, Clinical, and Supply Chain.

Leadership focuses on process validation, governance, and supplier management across contract manufacturers.