Principal Software Design Quality Engineer
Company: Disability Solutions
Location: Danvers
Posted on: May 9, 2024
|
|
Job Description:
Abiomed, a part of Johnson & Johnson MedTech is recruiting for a
Principal Software Design Quality Engineer located in Danvers, MA
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. This Principal Software Design Quality Engineer will
have a focus on supporting the Software as a Medical Device (SaMD)
projects at Abiomed. This includes cloud connected Medical Devices
and Medical Device Data Systems (MDDS). The engineer is responsible
for various design quality engineering functions in support of
development such as risk management, requirements and test reviews,
as well as other design controls activities on Medical Device
software. 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: --- Lead Design Quality
Engineering activities in support of Abiomed's Software Product
Development and Software Life Cycle processes for MDDS, CDS, IoT,
Multi-function devices, and SaMD. This includes design controls,
quality planning, risk assessments/analysis/management, design
reviews, test method development and validation, design and process
verification and validation test plans and reports, post-market
monitoring, investigations, follow-up and reporting --- Ensure that
Design controls are compliant with IEC 62304 and IEC 82304-1. ---
Support and ensure adherence to Abiomed's product security
processes. --- 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 Engineering
Change Orders (ECO) as needed --- Act as an effective team member
in the execution of Quality functions in compliance with FDA QSRs
(Design Control, CAPA, etc), ISO 13485, MDR, CMDR, CMDCAS 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, Westfield , Principal Software Design Quality Engineer, IT / Software / Systems , Danvers, Massachusetts
Click
here to apply!
|