Director, Manufacturing Engineering & External Operations

Kardion; United States; Hybrid; USD 200,000 - 220,000; Full time

Benefits offered by this job

Hybrid work model

Competitive compensation

Medical, dental, vision

401(k)

Paid time off

Job summary

Kardion in Irvine, CA is seeking a senior leader to lead and scale the Manufacturing Engineering & External Operations function for complex Class III interventional cardiovascular devices in a hybrid role.

You will oversee manufacturing industrialization, design transfer, and external manufacturing readiness with FDA and EU MDR frameworks, collaborating with R&D, Quality, Regulatory, Clinical, and Supply Chain.

Qualifications

• Bachelor's or higher engineering degree in a related field.
• 10+ years in Manufacturing Engineering, Industrialization, or Technical Operations in the medical device industry.
• Experience with Class III medical devices and outsourced manufacturing.
• Strong knowledge of FDA Design Controls, FDA QSR/QMSR, ISO 13485, ISO 14971, and EU MDR.

Responsibilities

• Lead and scale the Manufacturing Engineering & External Operations function in a virtual manufacturing environment.
• Oversee manufacturing industrialization, design transfer, and commercialization readiness for Class III devices from development through launch.
• Establish governance, KPIs, validation strategies, and supplier performance management.
• Collaborate with Quality, Regulatory, Clinical, R&D, and Supply Chain to support regulatory submissions and inspections.
• Drive continuous improvement across external manufacturing network to improve yield, throughput, and cost.

Skills

Fluent English

Education

Engineering degree (Engineering, Biomedical Engineering, Manufacturing Engineering)

Tools

IQ/OQ/PQ validation

PFMEA

Process capability

Job description

About Kardion

Kardion is a cardiovascular medical device company developing next-generation mechanical circulatory support technology, with dual headquarters in Irvine, California and Stuttgart, Germany. Every moment matters — our team is building toward a future where circulatory support gives patients and clinicians more time, more options, and more certainty.

Position Summary

Lead and scale the Manufacturing Engineering & External Operations function for complex Class III interventional cardiovascular medical devices supporting high-risk PCI (HRPCI) and related catheter-based therapies within a virtual manufacturing environment. This Irvine, California-based hybrid leadership role is responsible for manufacturing industrialization, supplier process validation oversight, design transfer, and external manufacturing readiness supporting clinical and commercial product launches under FDA and EU MDR frameworks. The role partners cross-functionally with R&D, Quality, Regulatory, Clinical, and Supply Chain to ensure robust, scalable, and inspection-ready manufacturing systems across contract manufacturing partners and critical suppliers.

Mission

• Build, lead, and develop the Manufacturing Engineering & External Operations function within a virtual manufacturing environment.
• Lead manufacturing industrialization, design transfer, and commercialization readiness for Class III interventional cardiovascular devices from development through commercial launch.
• Drive Design for Manufacturability (DFM), Design for Scalability, and technical transfer activities in close collaboration with R&D and external manufacturing partners.
• Oversee contract manufacturers and critical suppliers, ensuring robust process validation (IQ/OQ/PQ), manufacturing risk controls, process capability, and scalable production performance.
• Establish manufacturing governance frameworks, KPIs, validation strategies, and supplier performance management to ensure quality, compliance, and operational excellence.
• Partner closely with Quality, Regulatory, Clinical, and Supply Chain teams to support regulatory submissions, inspections, CAPA, change control, and global commercialization activities.
• Drive continuous improvement initiatives across the external manufacturing network to enhance manufacturability, yield, throughput, quality, and cost efficiency.
• Support manufacturing capacity planning, supplier industrialization, and long-term manufacturing scale-up strategies aligned with business growth objectives.

Profile

• Degree in Engineering, Biomedical Engineering, Manufacturing Engineering, or a related discipline.
• 10+ years of experience in Manufacturing Engineering, Industrialization, or Technical Operations within the medical device industry.
• Experience with Class III medical devices, catheter-based technologies, or other complex interventional products.
• Proven leadership experience in outsourced manufacturing environments, including supplier management, design transfer, and commercialization programs.
• Strong expertise in process validation (IQ/OQ/PQ), PFMEA, process capability, and manufacturing risk management.
• Solid knowledge of FDA Design Controls, FDA QSR/QMSR, ISO 13485, ISO 14971, and EU MDR.
• Fluent English; German is advantageous.
• Willingness to travel to Germany (up to approximately 30% of the time) to support supplier and CMO engagement.

Work Environment/Travel

On-site in Irvine, CA. Willingness to travel domestically and internationally, up to 30%, including to Kardion’s Stuttgart, Germany office. Occasional early or late meetings to overlap with the CET time zone.

Compensation

The anticipated base salary range for this position is $200,000 – $220,000 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.

Why Us

• Opportunity to shape and scale manufacturing operations for groundbreaking cardiovascular technologies.
• High-impact leadership role with significant influence on product commercialization and company growth.
• Collaborative, international, and innovation-driven environment.
• Flexible hybrid working model with direct exposure to suppliers and manufacturing partners.
• Competitive compensation and professional development opportunities.

Equal Opportunity Statement

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.