Test Engineer III

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.

What You'll Do:

• 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.

What You'll Bring:

• Experience:
  • Minimum 6 years (8+ years preferred) of experience in Design and Systems Verification within a demanding product development environment, ideally in medical devices.
• Education:
  • Bachelor's Degree in Electrical Engineering, Electrical and Computer Science, or equivalent. (Master’s or PhD in Engineering or MBA preferred).
• Technical Expertise:
  • 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.
  • 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.
• Soft Skills:
• • 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.

Why Karl Storz?

At Karl Storz, you'll be part of a team that's committed to innovation and excellence in medical technology. We offer:

• A challenging and rewarding role where your work directly impacts healthcare outcomes.
• 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.

Who We Are:

KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.

With more than 9,000 associates worldwide and 2,600 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities succeed. With onsite locations and field opportunities across the country, we attract a diverse and talented staff. It's not just about the tools we create—it’s about the lives we change, together.

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