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Abiomed · 2 days ago
Principal Software Design Quality Engineer
Danvers, MA
Full-time
Onsite
Senior Level
8+ years exp
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Responsibilities
Lead Design Quality Engineering activities for Software Product Development and Software Life Cycle processes.
Ensure compliance with IEC 62304 and IEC 82304-1 design control standards.
Support product security processes and regulatory knowledge application in risk management and testing.
Participate in design reviews, approve design input/output artifacts, and review Engineering Change Orders.
Execute Quality functions in compliance with FDA QSRs, ISO standards, and other regulatory requirements.
Contribute to product assurance plans, corrective actions, and supplier performance.
Ensure computerized quality systems compliance with regulations and company procedures.
Build and maintain strong interpersonal relationships within and outside the company.
Qualification
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Required
Bachelor degree in Engineering or Sciences is required, Masters preferred
8+ years of quality experience required
Minimum of 5 years experience in the medical device industry as well as Medical Device Software systems and cardiovascular devices highly preferred (Class III medical device experience strongly preferred)
Demonstrates strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements
Preferred
Familiarity with TIR45 and Agile methodologies preferred
Takes initiative and demonstrates leadership and teamwork
Company
Abiomed
Abiomed is a provider of mechanical circulatory support devices and offers a continuum of care to heart failure patients.
1,001-5,000 employees
H1B Sponsorship
Abiomed 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
2023 (7)
2022 (16)
2021 (20)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
unknown2022-11-01Acquired· by Johnson & Johnson ($16.6B)
2011-12-29Post Ipo Equity· Undisclosed
1987-08-07IPO· nasdaq:ABMD
Leadership Team
Todd Tetreault
Chief Financial Officer
Will Danzinger
Chief Operating Officer
Recent News
The Business Journals
2024-04-25
2024-04-25
Company data provided by crunchbase
