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.
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.

Benefits

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Hard Skills & Tools

Design VerificationTesting ProceduresSample-size AnalysisDesign Change AnalysisTest MethodologiesElectrical Test FixturesOptical Test FixturesMechanical Test FixturesAutomated TestingData Collection

Soft Skills

LeadershipMentorshipCollaborationTroubleshootingCommunicationInfluencingAnalytical SkillsProblem SolvingTechnical ConsultationPresentation Skills

Certifications

Bachelor's Degree in Electrical EngineeringBachelor's Degree in Electrical and Computer ScienceMaster’s Degree in EngineeringPhD in EngineeringMBA