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Company

Original Job Post

MindSource · 3 days ago

Principal Endoscope Architect

United States

Full-time

Remote

Senior Level

12+ years exp

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Information ServicesInformation Technology

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Responsibilities

Lead complex engineering projects related to single-use accessories, steerable catheters, and endoscope design.

Troubleshoot technical issues and optimize system performance.

Manage project budgets, resources, and timelines while focusing on quality and safety.

Transfer new products and processes to manufacturing.

Ensure compliance with regulatory standards such as IEC 60601-1 and FDA 510(k) submission process.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Engineering project managementRobotic platforms developmentProject budget managementResource managementQuality assuranceSafety complianceNew product developmentManufacturing transferSolidWorksCAD designPDM toolsRegulatory standardsRisk managementIEC 60601-1FDA 510(k) submissionIntellectual property translationStartup experienceProblem-solvingAnalytical thinkingAttention to detailEffective leadershipCommunication skills

Required

At least 12 years in leading complex engineering projects, including expertise in single use accessories, steerable catheter or endoscope design and manufacturing, with hands-on experience in developing robotic platforms preferred.

Excellent problem-solving skills, analytical thinking, and attention to detail, with the ability to troubleshoot technical issues and optimize system performance.

Effective leadership and communication skills, with the ability to explain complex problems and solutions in plain language to multi-disciplinary, cross-functional teams.

Demonstrated ability to manage project budgets, resources, and timelines effectively, while maintaining a focus on quality and safety.

Experience transferring new products and processes to manufacturing.

Advanced SolidWorks user with experience using SolidWorks CAD and PDM tools.

Strong understanding of regulatory standards such as IEC 60601-1 and FDA 510(k) submission process, including risk management, analysis, and mitigation.

Must have prior experience working in a fast-paced startup environment.

Demonstrated experience with translating insights into intellectual property.

BS in Mechanical Engineering, Mechatronics, Biomedical Engineering, or related field, MS or PhD preferred.

Company

MindSource

MindSource has delivered software solutions for over two decades to many hundreds of Silicon Valley companies.

Founded in 1994

Mountain View, California, USA

201-500 employees

https://www.mindsource.com

H1B Sponsorship

MindSource 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

Trends of Total Sponsorships

2021 (2)

2020 (1)