Sr Software Design Quality Engineer
Company: Disability Solutions
Location: Danvers
Posted on: May 3, 2024
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Job Description:
Abiomed, part of Johnson & Johnson MedTech, is currently
recruiting for a Sr Software Design Quality Engineer to be based in
Danvers, MA, onsite 3 days a week At Johnson & Johnson, we believe
health is everything. Our strength in healthcare innovation
empowers us to build a world where complex diseases are prevented,
treated, and cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in Innovative
Medicine and MedTech, we are uniquely positioned to innovate across
the full spectrum of healthcare solutions today to deliver the
breakthroughs of tomorrow, and profoundly impact health for
humanity. Learn more at https://www.jnj.com/. Abiomed, part of
Johnson & Johnson MedTech, is a leading provider of medical devices
that provide circulatory and respiratory support, with a mission of
recovering hearts & saving lives. Abiomed's "Patients First!"
culture drives our skilled workforce and strong relationships with
clinicians. Our innovative product portfolio and robust pipeline
provide us the incredible opportunity to bring lifesaving
technology to more patients around the world than ever before.
Founded in 1981, Abiomed has a proven track record for growth,
integrity and innovation. This Software Design Quality Engineer
position is responsible for various Design Quality Engineering
functions in support of product development on Software within a
Medical Device, specifically the Automated Impella Controller and
next generation iterations. This is to include activities such as
leading Risk Management activities, collaborating with development
teams throughout the Software Development Life Cycle, guiding teams
through Design Controls, and ensuring compliance to the Quality
Management System. Primary Duties and Responsibilities: The
following duties and responsibilities are intended to be
representative of the work performed by the incumbent(s) in this
position and are not all-inclusive. The omission of a specific duty
or responsibility will not preclude it from the position: --- Drive
quality focused design and development of software within the
software development lifecycle (Agile/waterfall/SAFe/DevOps) by
defining the requirements, design, verification and validation plan
and strategies while maintaining traceability --- Lead and conduct
risk management activities including system risk analysis and
software FMEA's --- Ensure that Design controls are compliant with
IEC 62304. --- Ensure that FDA and other regulatory knowledge and
experience is applied to risk management, software development, and
testing --- Participate in design reviews for the system as well as
review and approve design input/design output artifacts including
requirements, design documents, code review, test results,
verification and validation. --- Review and approve Change Requests
as needed to release software revisions to production/field --- Act
as an effective team member in the execution of Quality functions
in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485,
ISO 14971, IEC 62304, MDR, and other national and international
quality and regulatory requirements and standard --- Contribute to
the design, development and implementation of product assurance
plans providing feedback to corrective and preventative actions to
engineering, manufacturing, service and field operations and
supplier performance --- Partner with Manufacturing, Engineering,
and IT to ensure that computerized quality systems are compliant
with Abiomed procedures, FDA Quality System Regulations, 21 CFR
Part 11. --- Build and maintain strong interpersonal relationships
within and outside of the company
Keywords: Disability Solutions, Lowell , Sr Software Design Quality Engineer, IT / Software / Systems , Danvers, Massachusetts
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