Systems Engineer IV

Karl Storz Endoscopy; Goleta (CA); Hybrid; USD 114,000 - 148,000; Full time

Job summary

KARL STORZ Endoscopy is seeking an experienced Systems Engineer to lead design, architecture, integration, and verification of complex medical device systems. You will work with Product Management, PM, Manufacturing, Quality, Regulatory, and global teams to deliver products meeting customer needs and regulatory requirements.

This hybrid role features 4 10-hour shifts with Mondays remote, Tue–Thu in-office, and Fridays off.

Qualifications

• Bachelor’s, Master’s, or PhD in a technical field.
• 8+ years in a regulated industry with 5+ years in systems engineering leadership.
• Experience leading products through full development lifecycle.

Responsibilities

• Lead system-level design and architecture for medical device products across the product lifecycle.
• Own top-level system requirements and ensure alignment with customer needs and regulatory standards.
• Serve as Technical Lead within Product Ownership Team, driving technical decisions and analyses.
• Oversee integration of hardware, software, optical, and mechanical subsystems into a cohesive solution.
• Develop and execute system integration, verification, and validation strategies with traceability.
• Collaborate with regulatory, compliance, and external testing bodies for product certification.
• Provide technical support for sustaining engineering activities and continuous improvement.

Skills

System engineering

Technical leadership

Regulatory standards

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

PhD

Tools

Regulatory frameworks

Job description

About KARL STORZ

From the operating room to surgery centers-and everywhere in between-KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging-to build a more connected, software-enabled operating room.

As an independent, family-owned MedTech company, we ambitiously think in generations instead of quarters to improve patients' lives around the world.

About the Role

KARL STORZ is seeking an experienced Systems Engineer to lead the design, architecture, integration, and verification of complex medical device systems. In this highly visible role, you will serve as the technical lead within cross-functional product development teams, partnering with Product Management, Project Management, Manufacturing, Quality, Regulatory, and global engineering teams to deliver innovative products that meet customer needs, regulatory requirements, and business objectives.

This role has a hybrid work schedule - 4 10 hours shifts where Monday's are remote days, Tuesday - Thursday in office and Friday's are off. The compensation for this role falls between $113,900 - $148,100 and may flucuate greatly depending on experience for this position.Occasional domestic and international travel may be required.

What You'll Do

• Lead system-level design and architecture for complex medical device products throughout the product development lifecycle.
• Own top-level system requirements and ensure alignment with customer needs, regulatory standards, and business objectives.
• Serve as the Technical Lead within the Product Ownership Team, driving technical decisions, tradeoff analyses, and system performance.
• Oversee integration of hardware, software, optical, and mechanical subsystems into a cohesive solution.
• Develop and execute system integration, verification, and validation strategies while maintaining end-to-end requirements traceability.
• Collaborate with regulatory, compliance, and external testing bodies to support product certification and market readiness.
• Provide technical support for sustaining engineering activities, field investigations, and continuous product improvement.

What You Bring

• Bachelor's, Master's, or PhD in Electrical Engineering, Computer Engineering, Computer Science, Physics, or a related technical discipline.
• 8+ years of experience in a regulated industry, including 5+ years in a Systems Engineering or similar technical leadership role.
• Experience leading products through the complete product development lifecycle.
• Strong understanding of system architecture, requirements management, and systems integration.
• Knowledge of software development methodologies and microprocessor-controlled systems.
• Broad understanding of hardware, optical, and mechanical design principles.
• Excellent technical documentation, communication, and stakeholder management skills.

Nice to Have

• Medical device product development experience.
• Knowledge of FDA Quality System Regulations, ISO 13485, ISO 9001, or similar standards.
• Experience with image acquisition systems, image processing, or complex networked systems.

What Will Make You Successful

• Ability to balance technical performance, reliability, manufacturability, cost, and schedule considerations.
• Strong analytical and problem-solving capabilities when evaluating complex system challenges.
• Effective collaboration across multidisciplinary engineering and business teams.
• Attention to detail with a focus on quality, safety, and regulatory compliance.
• Ability to influence technical direction and communicate complex concepts to diverse stakeholders.
• Passion for innovation and continuous improvement in medical technology.

Why KARL STORZ?

Join KARL STORZ and be part of a team creating medical innovations that truly make a difference. Beyond technology, you'll be part of a culture that values talent as its greatest asset, empowering you to contribute to a mission that improves patient care worldwide.