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

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.