KARL STORZ North America · 6 hours ago
Test Engineer III
Goleta, CA
Full-time
Hybrid
Senior Level
6+ years expKARL STORZ North America is a global leader in endoscopic instruments and devices, seeking a talented Verification Engineer (Test Engineer III) to join their dynamic team. This role involves leading design verification activities for advanced imaging devices, developing test infrastructure, and ensuring compliance with regulatory requirements to support healthcare innovation.
Medical Device
Responsibilities
Lead Verification Efforts: Take charge as a lead verification engineer on projects, overseeing the entire design verification process for Karl Storz Imaging devices and systems
Design & Execute Robust Testing: Develop and execute thorough verification procedures and plans, including sample-size analysis and design change analysis, to rigorously test product quality, manufacturability, reliability, efficacy, and regulatory compliance
Develop Test Infrastructure: Design and implement sophisticated test infrastructure, including electrical, optical, and mechanical test fixtures, to effectively assess complex imaging characteristics
Analyze & Report: Collect, analyze, and clearly present test results in comprehensive technical reports for engineering review and FDA submissions
Troubleshoot & Innovate: Provide expert assistance to project teams in troubleshooting design issues, product returns, and field problems. Propose and develop new test methodologies and improvements
Collaborate & Influence: Work closely with systems and design engineering to establish clear, testable requirements, and ensure product specifications are comprehensive and testable
Mentorship & Leadership: Act as a subject matter expert, mentoring other test engineers, reviewing their work, and providing technical troubleshooting consultation
Regulatory Support: Support regulatory affairs by providing crucial documentation and expertise for 510(k) FDA submissions
Qualification
Required
Minimum 6 years of experience in Design and Systems Verification within a demanding product development environment, ideally in medical devices
Bachelor's Degree in Electrical Engineering, Electrical and Computer Science, or equivalent
Proven experience in Systems Verification and verifying complex devices and systems
Strong understanding of product system concepts, risks, and verification methodologies
Proficiency with Test Procedures and Requirements, including relevant tools (e.g., DOORS, PTC, Polarion)
Familiarity with environmental testing and equipment
Experience with development processes (V-model, Agile, Lean)
In-depth knowledge of medical device quality system regulations and standards (e.g., U.S. FDA 21CFR Part 820, ISO13485, ISO9001)
SAP software experience is required
Exceptional analytical skills and technical report writing abilities
Strong interpersonal and communication skills (verbal and written), including cross-cultural communication
Ability to build productive relationships with diverse stakeholders and collaborate effectively
Proficient in problem-solving and root cause analysis
High degree of accountability, decision-making capabilities, and resilience in a fast-paced environment
Positive mindset and a commitment to fostering a collaborative team culture
Excellent organizational and time management skills, with a focus on high productivity
Preferred
8+ years of experience in Design and Systems Verification within a demanding product development environment, ideally in medical devices
Master's or PhD in Engineering or MBA
Familiarity with high-level programming language/software like MATLAB, LabView, or similar for automated testing and data collection
Knowledge of Systems Engineering, Cyber Security, and Usability
Benefits
Opportunities for continuous learning and professional development.
A collaborative and supportive work environment.
Occasional intercontinental travel to collaborate with global development sites, vendors, and customers.
Company
KARL STORZ North America
KARL STORZ North America is a leader in endoscopic technology and imaging solutions across virtually all surgical specialties.
1001-5000 employees
H1B Sponsorship
KARL STORZ North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (10)
2023 (14)
2022 (6)
2021 (8)
2020 (10)
Funding
Current Stage
Late StageLeadership Team
Bethany Kucera
Senior Human Resources Business Partner
Eric Allen, SHRM-CP
Human Resources Business Partner
Company data provided by crunchbase