98 applicants

Company

Original Job Post

Vicarious Surgical Inc. · 2 days ago

Staff Design Quality Engineer

Waltham, MA

Full-time

Onsite

Senior Level

8+ years exp

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Responsibilities

Responsible for Design Controls and Risk Management processes for a complex robotic medical device.

Author and lead the establishment of the Risk Management File and Usability Engineering related activities for new product development per ISO 14971 and IEC 62366-1.

Lead design quality activities from requirements phase through development, V&V, design transfer to commercialization phase.

Review and support product requirements, test documentation, and design reviews.

Provide guidance on statistical techniques and their application to product and process testing.

Participate in regulatory activities including FDA 510(K) submissions and Notified Body assessments.

Create or review Document Change Orders.

Other duties as assigned.

Qualification

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ISO 13485FDA 21 CFR PART 820EU Medical Device RegulationsISO 14971 2019IEC 60601-1IEC 62366Risk ManagementUsability EngineeringTraining Development

Required

Bachelor's Degree in Engineering or another technical discipline or equivalent experience/ quality certifications.

8+ years of related experience, including working with a complex electro-mechanical medical device.

Strong understanding of ISO 13485, FDA 21 CFR PART 820, EU Medical Device Regulations.

Experience with ISO 14971:2019 Application of Risk Management, IEC 60601-1 Medical Electrical Equipment collateral standards, and IEC 62366 Usability Engineering of Medical Devices.

Able to create and execute training for team members on quality processes and systems.

Benefits

Monthly social events

Catered lunches

Company celebrations

Company

Vicarious Surgical Inc.

At Vicarious Surgical we are revolutionizing the field of surgical robotics.

Founded in 2014

Waltham, Massachusetts, USA

51-200 employees

http://www.vicarioussurgical.com

H1B Sponsorship

Vicarious Surgical Inc. 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)

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2022 (12)

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2020 (1)