Test Engineer III Job at KARL STORZ (Goleta)

Job Description

Are you a seasoned Verification Engineer with a passion for ensuring the highest quality in cutting-edge medical devices? Do you thrive in a challenging product development environment where your expertise directly impacts patient care? Karl Storz, a global leader in endoscopic instruments and devices, is seeking a talented Verification Engineer (Test Engineer III) to join our dynamic team. This is a pivotal role where you will lead and execute comprehensive design verification activities for our advanced imaging devices and systems. You'll be instrumental in developing robust test infrastructure, assessing image quality, and ensuring compliance with stringent optical, mechanical, and electrical requirements. Your contributions will directly support our mission to advance healthcare through innovative technology.

Job Responsibility

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

Requirements

Minimum 6 years (8+ years preferred) 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. (Master’s or PhD in Engineering or MBA preferred)
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

Nice to have

Familiarity with high-level programming language/software like MATLAB, LabView, or similar for automated testing and data collection is a plus
Knowledge of Systems Engineering, Cyber Security, and Usability is a plus

What we offer

Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!
3 weeks vacation, 11 holidays plus paid sick time
Up to 8 weeks of 100% paid company parental leave
includes maternal/ paternal leave, adoption, and fostering of a child
401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
Section 125 Flexible Spending Accounts
Life, STD, LTD & LTC Insurance
Tuition pre-imbursement
We prepay your tuition up to $5,250 per year!
Fitness reimbursement of up to $200 annually
Occasional intercontinental travel to collaborate with global development sites, vendors, and customers

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Test Engineer III

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